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CompletedNCT02538965Updated Jan 7, 2020Results posted

A Study of Lenalidomide in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 2 interventional study of Lenalidomide in Leukemia, Myeloid, sponsored by Celgene. Completed at 62 sites in 2 countries. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2020-01-07.

Sponsored by Celgene · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
1 Year to 18 Years
Sex
All
01

Study summary

To determine the activity of lenalidomide in the treatment of pediatric subjects with relapsed/refractory acute myeloid leukemia (AML) (with second or greater relapse or refractory to at least 2 prior induction attempts) measured by morphological complete response defined as either a CR or CRi within the first 4 cycles of treatment.

Read the detailed description

This is a multicenter, open-label, single-arm, Phase 2, Simon's Optimal two-stage design study, with an Optional Extension Phase (OEP), that will assess the activity, safety and pharmacokinetics (PK) of lenalidomide in pediatric subjects from 1 to ≤ 18 years of age with second or greater Relapsed or Refractory Acute Myeloid Leukemia (rrAML). A total of 43 evaluable participants (18 participants in Stage 1 and an additional 25 participants in Stage 2) are required for assessment of the primary endpoint. To allow for participants found to be unevaluable for the primary endpoint due to an incorrect diagnosis, not having a disease assessment post screening, or who discontinued prior to receiving lenalidomide, up to 4 additional participants may be enrolled for a maximum of 47 evaluable subjects across approximately 70 sites. Approximately 50% of enrolled participants will be younger than 12 years of age to provide adequate PK data for this age subset.

If during Stage 1, at least 3 of 18 participants achieve a morphologic complete response (either CR or CRi) within the first 4 cycles of study treatment, then the study will proceed to Stage 2; otherwise, the study will be terminated. Similarly, if at the final analysis, at least 8 of 43 evaluable subjects across Stages 1 and 2 achieve a response (CR/CRi) within the first 4 cycles of study treatment, it will be concluded that lenalidomide has sufficient activity in pediatric Acute Myeloid Leukemia (AML) to warrant subsequent study. The optional extension phase (OEP) will allow participants who demonstrate clinical benefit, as assessed by the Investigator at the completion of 12 cycles of lenalidomide therapy, to continue receiving oral lenalidomide until they meet the criteria for study discontinuation. In the OEP, only safety, dosing, concomitant medications/procedures, and second primary malignancies (SPMs) will be monitored.

02

Conditions studied

  • Leukemia, Myeloid

Keywords

  • Lenalidomide
  • Revlimid
  • Pediatric
  • Relapsed or Refractory
  • Acute Myeloid Leukemia
  • Leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 17 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants must satisfy the following criteria to be enrolled in the study:
  1. Male or female is 1 to ≤ 18 years of age at the time of signing the Informed Consent Form / Informed Assent Form (ICF/IAF).
  2. Participants (when applicable, parental/legal representative) must understand and voluntarily provide permission to the ICF/IAF prior to conducting any study-related assessments/procedures.

  3. Participants have relapsed or refractory acute myeloid leukemia after at least 2 prior induction attempts:

    • Bone marrow aspirate or biopsy must have ≥ 5% blasts by morphology and/or flow cytometry.
    • Each block of chemotherapy is a separate reinduction attempt.
    • Donor lymphocyte infusion (DLI) is considered a reinduction attempt.
  4. Participants are willing and able to adhere to the study visit schedule and other protocol requirements.
  5. Participants have a Karnofsky score of ≥ 50% (participants ≥ 16 years of age) or a Lansky score ≥ 50% (participants \< 16 years of age).
  6. Participants have a resting left ventricular ejection fraction (LVEF) of ≥ 40% obtained by echocardiography.
  7. Participants have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to first dose. All prior treatment-related toxicities must have resolved to ≤ Grade 2 prior to enrollment.

  8. Regarding radiation therapy, time elapsed prior to first dose of lenalidomide:

    • 2 weeks for local palliative radiation therapy (XRT).
    • 8 weeks if prior craniospinal chemoradiation therapy (CRT) or if ≥ 50% radiation of pelvis.
    • 6 weeks if other bone marrow radiation has been administered.

  9. Graft-versus-host disease criteria:

    • Participants must be at least 2 months (from first dose of lenalidomide) from stem cell infusion.
    • Participants must have no evidence of active acute or chronic GVHD (Grade 0) for 4 weeks prior to the first dose of lenalidomide.

    • If the participants have a history of maximum Grade 1 or 2 GVHD that was treated with systemic steroid (≥ 0.5 mg/kg/day prednisone equivalents) or other non-steroid systemic IST, the participant must be off all IST for at least 2 weeks, and must have ceased treatment doses of steroids for GVHD (≥ 0.5 mg/kg/day prednisone equivalents) for at least 4 weeks.

      • If the participants have a history of Grade 3 or greater GVHD, the participants must be off all systemic IST for 4 weeks
      • Topical therapy is permitted and does not imply the participants have active acute or chronic GVHD.
    • Physiologic dosing of hydrocortisone is permitted.
  10. At least 4 weeks (from first dose) elapsed from donor lymphocyte infusion (DLI) without conditioning.

  11. Participants have adequate renal function, which is defined as:

    • Creatinine clearance calculated using the Schwartz formula, or radioisotope glomerular filtration rate (GFR) > 70 mL/min/1.73 m2.

  12. Participants have adequate liver function, which is defined as:

    • Total bilirubin is ≤ 2 mg/dL unless the increase in bilirubin is attributable to Gilbert's Syndrome
    • Aspartate aminotransferase (AST) is ≤ 3.0 x upper normal limit (ULN) for age. For the purpose of this study, the ULN for AST is 50 U/L.
    • Alanine transaminase (ALT) is ≤ 3.0 x upper normal limit (ULN) for age. For the purpose of this study, the ULN for ALT is 45 U/L.
  13. Female Children of Childbearing Potential (FCCBP), Female of Childbearing Potential (FCBP) and male participants that have reached puberty must agree to undergo physician-approved reproductive education and discuss the side effects of the study therapy on reproduction with parent(s) and/or guardian(s).

  14. All participants and/or parents/guardians must have an understanding that lenalidomide could have a potential teratogenic risk. Female children of childbearing potential, is defined as females who have achieved menarche and/or breast development in Tanner Stage 2 or greater and have not undergone a hysterectomy or bilateral oophorectomy and FCBP defined as a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) must meet the following conditions below (Note: Amenorrhea following cancer therapy does not rule out childbearing potential):

    • Medically supervised serum pregnancy tests with a sensitivity of at least 25 mIU/mL must be conducted in FCCBP/FCBP, including those who commit to complete abstinence*. FCCBP/FCBP must have two pregnancy tests (with a minimum sensitivity of 25 mIU/mL) prior to starting treatment with lenalidomide. The first pregnancy test must be performed within 10 - 14 days prior to the start of lenalidomide treatment and the second pregnancy test must be performed within 24 hours prior to starting treatment with lenalidomide.

NOTE: The pregnancy test 10 to 14 days prior to initiation of lenalidomide may be omitted, at the discretion of the investigator, for any FCCBP/FCBP who has high acuity disease requiring immediate treatment with lenalidomide. The pregnancy test within 24 hours prior to the first dose of lenalidomide is required to be performed.

The participants may not received Investigational Product (IP) until the investigator has verified that the results of these pregnancy tests performed on Cycle 1 Day 1 are negative. FCCBP/FCBP with regular or no menstrual cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study Treatment Discontinuation Visit, and at Day 28 following IP discontinuation. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study Treatment Discontinuation Visit, and at Days 14 and 28 following IP discontinuation.

  • Female participants must, as appropriate to age and at the discretion of the study Investigator, either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) and/or agree to the use of two reliable forms of approved and effective contraceptive methods simultaneously. The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) without interruption, 28 days prior to starting lenalidomide treatment, throughout the entire duration of study treatment including dose interruptions and 28 days after the end of study treatment.

  • All male and female participants must follow all requirements defined in the Pregnancy Prevention Program.

    1. Male participants, as appropriate to age and the discretion of the study physician:
  • Must practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following lenalidomide discontinuation, even if he has undergone a successful vasectomy or practices complete abstinence.

Exclusion criteria

Exclusion Criteria:

  1. Participants have Down syndrome.
  2. Participants have French-American-British classification (FAB) type M3 leukemia (acute promyelocytic leukemia) or identification of t(15;17).
  3. Participants have isolated central nervous system (CNS) involvement or extramedullary relapse. (Participants with combined CNS/marrow relapse may be enrolled).
  4. Participants had prior treatment with cytotoxic chemotherapy within 2 weeks of the first dose of lenalidomide with the exception of hydroxyurea (allowed prior to the first dose of lenalidomide and through Day 14 of Cycle 1) and intrathecal (IT) cytarabine will be administered within 2 weeks prior to administration of lenalidomide.
  5. Participants have had prior treatment with biologic antineoplastic agents less than 7 days before the first dose of lenalidomide. For agents that have known adverse events (AEs) occurring beyond 7 days after administration (ie, monoclonal antibodies), this period must be extended beyond the time during which acute AEs are known to occur.
  6. Participants have had prior treatment with lenalidomide.
  7. Participant is pregnant or lactating.
  8. Participants have an uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment).
  9. Participants has known Human Immunodeficiency Virus (HIV) positivity (participants who are receiving antiretroviral therapy for HIV disease).
  10. Participants have a prior history of malignancies other than AML unless the subject has been free of the disease for ≥ 5 years from first dose of lenalidomide.

  11. The presence of any of the following will exclude a participant from enrollment:

    • Participants have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
    • Participants have any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.
    • Participants have any condition that confounds the ability to interpret data from the study.
  12. Participants have cardiac disorders (Common Terminology Criteria for Adverse Events [CTCAE] version 4.03 Grade 3 or 4).
  13. Participants have a history of well-documented prior veno-occlusive disease (VOD).
  14. Participants have any other organ dysfunction (CTCAE version 4.03 Grade 4) that will interfere with the administration of the therapy according to this protocol.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Lenalidomide

    Lenalidomide API will administered at a starting dose of 2 mg/kg/day. Lenalidomide will be provided as either a capsule (2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg or 25 mg) or as an oral suspension (10mg/mL).

    Drug: Lenalidomide

Interventions

  • DrugLenalidomide

    Lenalidomide will be administered orally once daily for the first 21 days of every 28-day cycle. The starting dose will be 2 mg/kg/day with a maximum dose of 70 mg/day. Number of cycles: 12, or until evidence of progressive disease. Participants will also be discontinued if unresolved toxicities as described in the protocol occur, or if dose reductions are required and subject does not tolerate minimum dose level of 1mg/kg/day.

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Achieved a Morphologic Complete Response Within the First Four Cycles of Lenalidomide Treatment According to the Modified International Working Group (IWG) Criteria

    The morphological complete response rate was defined as the total number of participants with morphological CR observed within the first 4 cycles of lenalidomide (regardless of whether the CR/CRi was observed at the end of Cycle 1, 2, 3 or 4) over the total number of participants evaluable for this endpoint. According to Modified IWG criteria, morphologic CR was defined as: 1. Absolute neutrophil count (ANC) ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support (i.e., no transfusion or exogenous growth factor within 7 days of assessment; 2. Bone marrow \< 5% blasts evidence of trilineage hematopoiesis; 3. No evidence of extramedullary disease. Morphologic CRi was defined as: 1. ANC \< 1000/μL and platelets \< 100,000/μL or \> 100,000/μL without platelet recovery (requiring transfusion within 7 days of assessment); 2. BM with \< 5% blasts and evidence of trilineage hematopoiesis; 3. No evidence of extramedullary disease.

    Time frame: From day of the first dose of IP to end of cycle 4; Response was assessed at the completion of the 21-day treatment period of cycles 1, 2, 3, and 4 and at treatment discontinuation.

Secondary outcomes

  1. Number of Participants Who Achieved a Bone Marrow Confirmed CR/CRi Lasting 3 Months (Durable Response Rate)

    Durable response rate was defined as the percentage of participants who achieved a BM confirmed CR/CRi according to the Modified IWG Response Assessment Lasting 3 Months (from the time to complete response observed until treatment failure or worse) or until transplantation if earlier among all participants eligible for durable response rate analysis, provided the CR/CRi was confirmed in a bone marrow sample). Due to scarcity of relevant data, it was not practical or meaningful to analyze the durable response rate. Only 1 participant had a response and the participant was censored soon after, as the consent was withdrawn; unable to calculate duration of response.

    Time frame: From date of confirmed complete response observed until treatment failure or worse; up to data cut-off date of 31 December 2017

  2. Duration of Response

    Duration of response was defined as the time from date of the first observed response (CR, CRi or PR) until morphologic relapse, molecular/cytogenetic relapse, or death only for participants who achieved a response. Due to scarcity of relevant data, it was not practical or meaningful to analyze the duration of response. Only 1 participant had a response and the participant was censored soon after, as the consent was withdrawn; unable to calculate duration of response.

    Time frame: From date of first time of complete response observed until treatment failure or worse; up to data cut-off date of 31 December 2017

  3. Number of Participants Who Achieved a Best Response of Morphologic Complete Remission, Morphologic Complete Remission Incomplete or Partial Remission

    Overall response rate was defined as the number of participants with best response of CR, CRi or PR. A CR was defined as: 1. ANC ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support (no transfusion or exogenous growth factor within 7 days of assessment); 2. BM \< 5% blasts evidence of trilineage hematopoiesis; 3. No evidence of extramedullary disease. A CRi was defined as: 1. ANC \< 1000/μL and platelets \< 100,000/μL or \> 100,000/μL without platelet recovery (requiring transfusion within 7 days of assessment); 2. BM with \< 5% blasts and evidence of trilineage hematopoiesis; 3. No evidence of extramedullary disease. A PR was defined as: 1. ANC of ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support (no transfusion or exogenous growth factor within 7 days of assessment); 2. BM with 5% to 25% blasts and at least a 50% decrease in BM blast percent from baseline; 3. No evidence of extramedullary disease.

    Time frame: Response was assessed at the completion of the 21-day treatment period of cycles 1, 2, 3.

  4. Number of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3

    Disease assessment outcome at the end of Cycles 1-3 based on Cheson criteria: Morphologic CR = 1. ANC ≥ 1000/μL and platelet ≥ 100,000 without transfusions and/or exogenous growth factor support (no transfusion or exogenous growth factor within 7 days of assessment) 2. BM \< 5% blasts evidence of trilineage hematopoiesis 3. No evidence of extramedullary disease Morphologic CRi = 1. ANC\< 1000/μL and Platelets \< 100,000/μL or \> 100,000/μL without platelet recovery (requiring transfusion within 7 days of assessment) 2. BM with \< 5% blasts and evidence of trilineage hematopoiesis 3. No evidence of extramedullary disease PR = 1. ANC ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support 2. BM with \< 5%-25% blasts and at least a 50% decrease in BM blast percent from baseline 3. No evidence of extramedullary disease Treatment Failure = resistant disease; survival ≥ 7 days post-therapy; failed to achieve CR, CRi, or PR but stable with persistent AML

    Time frame: Response was assessed at the completion of the 21-day treatment period of cycles 1, 2, 3.

  5. Number of Participants Who Received a Haematopoietic Stem Cell Transplant (HSCT)

    The number of participants who had undergone a haematopoietic stem cell transplant was calculated over the total number of participants in the ITT population. Percentages were also calculated based on whether the transplantation was the first, second, or subsequent transplant post IP administration.

    Time frame: From first dose of study drug up to 5 years post HSCT

  6. Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)

    A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of lenalidomide and within 28 days after the last dose. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.3 and based on the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.

    Time frame: From the first dose of study drug until 28 days after the last dose of study drug; up to data cut off date of 31 December 2017; maximum duration of treatment was 12 weeks

  7. Percentage of Participants With of Graft Versus Host Disease (GVHD)

    Acute graft versus host disease generally occurs after allogeneic hematopoietic stem cell transplantation. It is a reaction of donor immune cells against host tissues. The 3 main tissues that acute GVHD affects are the skin, liver, and gastrointestinal tract. Chronic GVHD is scored per the National Institute of Health consensus conference grading system. Clinical manifestations of chronic GVHD include skin involvement resembling lichen planus or the cutaneous manifestations of scleroderma; dry oral mucosa with ulcerations and sclerosis of the gastrointestinal tract; and a rising serum bilirubin concentration.

    Time frame: From the first dose of study drug to 28 days after the last dose of study drug; up to data cut off date of 31 December 2017; maximum treatment was 12 weeks

  8. Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Lenalidomide (AUC-t)

    Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations were increasing and the logarithmic trapezoidal method when concentrations were decreasing.

    Time frame: Pharmacokinetic (PK) sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.

  9. Area Under the Plasma Concentration Time Curve From 0 Extrapolated to Infinity (AUC-inf, AUC0∞) Of Lenalidomide

    Area under the plasma concentration-time curve from time 0 extrapolated to infinity, calculated as \[AUCt + Ct/ λz\]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz.

    Time frame: Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.

  10. Maximum Observed Concentration (Cmax) of Lenalidomide

    Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.

    Time frame: PK sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.

  11. Time to Reach Maximum Concentration (Tmax) of Lenalidomide

    Time to cmax was obtained directly from the observed concentration versus time data.

    Time frame: Pk sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.

  12. Terminal Half-Life (t1/2) of Lenalidomide

    Terminal phase half-life in plasma, calculated as \[(ln 2)/λz\]. Terminal half-life was only calculated when a reliable estimate for λz could be obtained.

    Time frame: Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.

  13. Apparent Total Clearance (CL/F) of Lenalidomide

    Apparent volume of distribution, calculated as \[(CL/F)/λz\].

    Time frame: Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.

  14. Apparent Volume of Distribution (Vz/F) of Lenalidomide

    Apparent volume of distribution, calculated as \[(CL/F)/λz\].

    Time frame: Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.

  15. Correlation of Peripheral White Blood Cell Count, Absolute Blast Count and Cytogenetics With Response to Lenalidomide

    Correlation of peripheral white blood cell count, absolute blast count and cytogenetics with response to lenalidomide was not performed since only 1 participant met the primary efficacy endpoint of morphological CR/CRi, and due to scarcity of relevant data, it was not practical or meaningful to analyze to perform the analysis on blood counts and response to lenalidomide.

    Time frame: Not Performed

07

Results

Posted Sep 20, 2018
Limitations and caveats
The results of the efficacy analysis were reviewed by an independent Data Monitoring Committee, which concluded that the study would not proceed to Stage 2, given that the efficacy criteria for continuation of the study to Stage 2 had not been met.

Participant flow

Participants were enrolled at 15 centers within the United States and Canada.

Treatment Period
Participant flow — Treatment Period
MilestoneLenalidomide
Started17
Completed0
Not completed17
Withdrew: Other = death due to disease progression1
Withdrew: Adverse event2
Withdrew: Withdrawal by parent/guardian2
Withdrew: Treatment failure9
Withdrew: Disease progression1
Withdrew: Physician decision2
Follow-Up Period
Participant flow — Follow-Up Period
MilestoneLenalidomide
Started17
Completed0
Not completed17
Withdrew: Other = death due to disease progression13
Withdrew: Withdrawal by parent4

Outcome measures

PrimaryNumber of Participants Who Achieved a Morphologic Complete Response Within the First Four Cycles of Lenalidomide Treatment According to the Modified International Working Group (IWG) Criteria

The morphological complete response rate was defined as the total number of participants with morphological CR observed within the first 4 cycles of lenalidomide (regardless of whether the CR/CRi was observed at the end of Cycle 1, 2, 3 or 4) over the total number of participants evaluable for this endpoint. According to Modified IWG criteria, morphologic CR was defined as: 1. Absolute neutrophil count (ANC) ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support (i.e., no transfusion or exogenous growth factor within 7 days of assessment; 2. Bone marrow \< 5% blasts evidence of trilineage hematopoiesis; 3. No evidence of extramedullary disease. Morphologic CRi was defined as: 1. ANC \< 1000/μL and platelets \< 100,000/μL or \> 100,000/μL without platelet recovery (requiring transfusion within 7 days of assessment); 2. BM with \< 5% blasts and evidence of trilineage hematopoiesis; 3. No evidence of extramedullary disease.

Time frame:
From day of the first dose of IP to end of cycle 4; Response was assessed at the completion of the 21-day treatment period of cycles 1, 2, 3, and 4 and at treatment discontinuation.
Reported as:
Count of participants · Participants
Number of Participants Who Achieved a Morphologic Complete Response Within the First Four Cycles of Lenalidomide Treatment According to the Modified International Working Group (IWG) Criteria
ParticipantsLenalidomide
Number of Participants Who Achieved a Morphologic Complete Response Within the First Four Cycles of Lenalidomide Treatment According to the Modified International Working Group (IWG) Criteria1 (0.1 to 28.7)
SecondaryNumber of Participants Who Achieved a Bone Marrow Confirmed CR/CRi Lasting 3 Months (Durable Response Rate)

Durable response rate was defined as the percentage of participants who achieved a BM confirmed CR/CRi according to the Modified IWG Response Assessment Lasting 3 Months (from the time to complete response observed until treatment failure or worse) or until transplantation if earlier among all participants eligible for durable response rate analysis, provided the CR/CRi was confirmed in a bone marrow sample). Due to scarcity of relevant data, it was not practical or meaningful to analyze the durable response rate. Only 1 participant had a response and the participant was censored soon after, as the consent was withdrawn; unable to calculate duration of response.

Time frame:
From date of confirmed complete response observed until treatment failure or worse; up to data cut-off date of 31 December 2017

No measurements were reported for this outcome.

SecondaryDuration of Response

Duration of response was defined as the time from date of the first observed response (CR, CRi or PR) until morphologic relapse, molecular/cytogenetic relapse, or death only for participants who achieved a response. Due to scarcity of relevant data, it was not practical or meaningful to analyze the duration of response. Only 1 participant had a response and the participant was censored soon after, as the consent was withdrawn; unable to calculate duration of response.

Time frame:
From date of first time of complete response observed until treatment failure or worse; up to data cut-off date of 31 December 2017

No measurements were reported for this outcome.

SecondaryNumber of Participants Who Achieved a Best Response of Morphologic Complete Remission, Morphologic Complete Remission Incomplete or Partial Remission

Overall response rate was defined as the number of participants with best response of CR, CRi or PR. A CR was defined as: 1. ANC ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support (no transfusion or exogenous growth factor within 7 days of assessment); 2. BM \< 5% blasts evidence of trilineage hematopoiesis; 3. No evidence of extramedullary disease. A CRi was defined as: 1. ANC \< 1000/μL and platelets \< 100,000/μL or \> 100,000/μL without platelet recovery (requiring transfusion within 7 days of assessment); 2. BM with \< 5% blasts and evidence of trilineage hematopoiesis; 3. No evidence of extramedullary disease. A PR was defined as: 1. ANC of ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support (no transfusion or exogenous growth factor within 7 days of assessment); 2. BM with 5% to 25% blasts and at least a 50% decrease in BM blast percent from baseline; 3. No evidence of extramedullary disease.

Time frame:
Response was assessed at the completion of the 21-day treatment period of cycles 1, 2, 3.
Reported as:
Count of participants · Participants
Number of Participants Who Achieved a Best Response of Morphologic Complete Remission, Morphologic Complete Remission Incomplete or Partial Remission
ParticipantsLenalidomide
Number of Participants Who Achieved a Best Response of Morphologic Complete Remission, Morphologic Complete Remission Incomplete or Partial Remission1
SecondaryNumber of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3

Disease assessment outcome at the end of Cycles 1-3 based on Cheson criteria: Morphologic CR = 1. ANC ≥ 1000/μL and platelet ≥ 100,000 without transfusions and/or exogenous growth factor support (no transfusion or exogenous growth factor within 7 days of assessment) 2. BM \< 5% blasts evidence of trilineage hematopoiesis 3. No evidence of extramedullary disease Morphologic CRi = 1. ANC\< 1000/μL and Platelets \< 100,000/μL or \> 100,000/μL without platelet recovery (requiring transfusion within 7 days of assessment) 2. BM with \< 5% blasts and evidence of trilineage hematopoiesis 3. No evidence of extramedullary disease PR = 1. ANC ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support 2. BM with \< 5%-25% blasts and at least a 50% decrease in BM blast percent from baseline 3. No evidence of extramedullary disease Treatment Failure = resistant disease; survival ≥ 7 days post-therapy; failed to achieve CR, CRi, or PR but stable with persistent AML

Time frame:
Response was assessed at the completion of the 21-day treatment period of cycles 1, 2, 3.
Reported as:
Count of participants · Participants
Number of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3
ParticipantsLenalidomide
Cycle 1 Morphologic CR0
Cycle 1 Morphologic CRi0
Cycle 1 PR1
Cycle 1 Treatment Failure13
Cycle 2 Morphologic CR0
Cycle 2 Morphologic CRi1
Cycle 2 PR0
Cycle 2 Treatment Failure5
Cycle 3 Morphologic CR0
Cycle 3 Morphologic CRi1
Cycle 3 PR0
Cycle 3 Treatment Failure0
SecondaryNumber of Participants Who Received a Haematopoietic Stem Cell Transplant (HSCT)

The number of participants who had undergone a haematopoietic stem cell transplant was calculated over the total number of participants in the ITT population. Percentages were also calculated based on whether the transplantation was the first, second, or subsequent transplant post IP administration.

Time frame:
From first dose of study drug up to 5 years post HSCT
Reported as:
Count of participants · Participants
Number of Participants Who Received a Haematopoietic Stem Cell Transplant (HSCT)
ParticipantsLenalidomide
Any Transplant After Treatment Start2
First Transplant After Treatment Start2
Second Transplant After Treatment Start0
Any Subsequent Transplant After Treatment Start0
SecondaryNumber of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)

A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of lenalidomide and within 28 days after the last dose. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.3 and based on the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.

Time frame:
From the first dose of study drug until 28 days after the last dose of study drug; up to data cut off date of 31 December 2017; maximum duration of treatment was 12 weeks
Reported as:
Count of participants · Participants
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)
ParticipantsLenalidomide
Any TEAE17
Any TEAE Related to Lenalidomide15
Any Grade 3/4 TEAE17
Any Grade 3/4 TEAE Related to Lenalidomide11
Any Grade 5 TEAE1
Any Serious TEAE13
Any Serious TEAE Related to Lenalidomide5
Any Serious TEAE Leading to Dose Discontinuation3
Any TEAE Leading to Dose Discontinuation3
Any TEAE Leading to Dose Reduction4
Any TEAE Leading to Dose Interruption7
Any TEAE Leading to Death1
SecondaryPercentage of Participants With of Graft Versus Host Disease (GVHD)

Acute graft versus host disease generally occurs after allogeneic hematopoietic stem cell transplantation. It is a reaction of donor immune cells against host tissues. The 3 main tissues that acute GVHD affects are the skin, liver, and gastrointestinal tract. Chronic GVHD is scored per the National Institute of Health consensus conference grading system. Clinical manifestations of chronic GVHD include skin involvement resembling lichen planus or the cutaneous manifestations of scleroderma; dry oral mucosa with ulcerations and sclerosis of the gastrointestinal tract; and a rising serum bilirubin concentration.

Time frame:
From the first dose of study drug to 28 days after the last dose of study drug; up to data cut off date of 31 December 2017; maximum treatment was 12 weeks
Reported as:
Number · Percentage of Participants
Percentage of Participants With of Graft Versus Host Disease (GVHD)
Percentage of ParticipantsLenalidomide
Percentage of Participants With of Graft Versus Host Disease (GVHD)0
SecondaryArea Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Lenalidomide (AUC-t)

Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations were increasing and the logarithmic trapezoidal method when concentrations were decreasing.

Time frame:
Pharmacokinetic (PK) sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.
Reported as:
Geometric mean · ng*h/mL
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Lenalidomide (AUC-t)
ng*h/mLLenalidomide
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Lenalidomide (AUC-t)5378.83 ± 57.3
SecondaryArea Under the Plasma Concentration Time Curve From 0 Extrapolated to Infinity (AUC-inf, AUC0∞) Of Lenalidomide

Area under the plasma concentration-time curve from time 0 extrapolated to infinity, calculated as \[AUCt + Ct/ λz\]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz.

Time frame:
Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.
Reported as:
Geometric mean · ng*h/mL
Area Under the Plasma Concentration Time Curve From 0 Extrapolated to Infinity (AUC-inf, AUC0∞) Of Lenalidomide
ng*h/mLLenalidomide
Area Under the Plasma Concentration Time Curve From 0 Extrapolated to Infinity (AUC-inf, AUC0∞) Of Lenalidomide5656.67 ± 52.8
SecondaryMaximum Observed Concentration (Cmax) of Lenalidomide

Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.

Time frame:
PK sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.
Reported as:
Geometric mean · ng/mL
Maximum Observed Concentration (Cmax) of Lenalidomide
ng/mLLenalidomide
Maximum Observed Concentration (Cmax) of Lenalidomide1252.08 ± 43.8
SecondaryTime to Reach Maximum Concentration (Tmax) of Lenalidomide

Time to cmax was obtained directly from the observed concentration versus time data.

Time frame:
Pk sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.
Reported as:
Median · Hours
Time to Reach Maximum Concentration (Tmax) of Lenalidomide
HoursLenalidomide
Time to Reach Maximum Concentration (Tmax) of Lenalidomide2.000 (0.5500 to 4.000)
SecondaryTerminal Half-Life (t1/2) of Lenalidomide

Terminal phase half-life in plasma, calculated as \[(ln 2)/λz\]. Terminal half-life was only calculated when a reliable estimate for λz could be obtained.

Time frame:
Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.
Reported as:
Geometric mean · hours
Terminal Half-Life (t1/2) of Lenalidomide
hoursLenalidomide
Terminal Half-Life (t1/2) of Lenalidomide2.311 ± 43.3
SecondaryApparent Total Clearance (CL/F) of Lenalidomide

Apparent volume of distribution, calculated as \[(CL/F)/λz\].

Time frame:
Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.
Reported as:
Geometric mean · ml/min
Apparent Total Clearance (CL/F) of Lenalidomide
ml/minLenalidomide
Apparent Total Clearance (CL/F) of Lenalidomide172.09 ± 52.5
SecondaryApparent Volume of Distribution (Vz/F) of Lenalidomide

Apparent volume of distribution, calculated as \[(CL/F)/λz\].

Time frame:
Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.
Reported as:
Geometric mean · Liters
Apparent Volume of Distribution (Vz/F) of Lenalidomide
LitersLenalidomide
Apparent Volume of Distribution (Vz/F) of Lenalidomide34.42 ± 57.0
SecondaryCorrelation of Peripheral White Blood Cell Count, Absolute Blast Count and Cytogenetics With Response to Lenalidomide

Correlation of peripheral white blood cell count, absolute blast count and cytogenetics with response to lenalidomide was not performed since only 1 participant met the primary efficacy endpoint of morphological CR/CRi, and due to scarcity of relevant data, it was not practical or meaningful to analyze to perform the analysis on blood counts and response to lenalidomide.

Time frame:
Not Performed

No measurements were reported for this outcome.

Adverse events

Collected over From the date of the first dose of lenalidomide until 28 days after the last dose of lenalidomide; up to the date the last patient discontinued follow-up 11 January 2019; maximum treatment duration was 12 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lenalidomide13/17 (76.5%)13/17 (76.5%)17/17 (100%)
Most frequent serious events
Showing 10 of 30
Most frequent serious events
EventLenalidomide
Febrile neutropeniaBlood and lymphatic system disorders6/17
CellulitisInfections and infestations2/17
PneumoniaInfections and infestations2/17
HypoxiaRespiratory, thoracic and mediastinal disorders2/17
Haemolytic anaemiaBlood and lymphatic system disorders1/17
LeukocytosisBlood and lymphatic system disorders1/17
Vitreous haemorrhageEye disorders1/17
DiarrhoeaGastrointestinal disorders1/17
StomatitisGastrointestinal disorders1/17
VomitingGastrointestinal disorders1/17
Most frequent other events
Showing 10 of 111
Most frequent other events
EventLenalidomide
AnaemiaBlood and lymphatic system disorders10/17
ThrombocytopeniaBlood and lymphatic system disorders10/17
NauseaGastrointestinal disorders9/17
HypokalaemiaMetabolism and nutrition disorders9/17
ConstipationGastrointestinal disorders7/17
PyrexiaGeneral disorders7/17
Abdominal painGastrointestinal disorders6/17
HeadacheNervous system disorders6/17
Back painMusculoskeletal and connective tissue disorders5/17
Oropharyngeal painRespiratory, thoracic and mediastinal disorders5/17

Baseline characteristics

The intention to treat (ITT) population consisted of all enrolled participants regardless of whether they received lenalidomide.

Age, Continuous
Age, Continuous(years)Lenalidomide
Mean11.5 ± 4.56
Sex: Female, Male
Sex: Female, Male(Participants)Lenalidomide
Female7
Male10
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Lenalidomide
Asian1
Black or African American0
White12
Not Collected or Reported3
Other1
Age Categories
Age Categories(Participants)Lenalidomide
≤ 2 years0
3-6 years4
7-12 years6
13-16 years4
≥ 17 years3
Peripheral Blood Smear Blasts
Peripheral Blood Smear Blasts(Percent of Blasts)Lenalidomide
Median8.7 (0 to 91)
White Blood Cell Count
White Blood Cell Count(10^9/L)Lenalidomide
Median3.700 (0.13 to 158.90)
Bone Marrow (BM) Myeloblasts Count
Bone Marrow (BM) Myeloblasts Count(Percent of Myeloblasts)Lenalidomide
Median57.5 (7 to 92)
Number of Participants With at Least One Cytogenetic Abnormality
Number of Participants With at Least One Cytogenetic Abnormality(Participants)Lenalidomide
t(8;21)1
+81
complex (>/= 3 abnormalities)5
-71
7q-2
11q 23 abnormalities3
inv (3)1
Other9

1 further baseline measures are reported on the registry.

08

Study locations

62 sites
  • Children's Hospital
    Birmingham, Alabama 35294, United States
  • Phoenix Childrens Hospital
    Phoenix, Arizona 85016, United States
  • Arkansas Children's Hospital
    Little Rock, Arkansas 72202, United States
  • Miller Children's Hospital
    Long Beach, California 90806, United States
  • Children's Hospital of Los Angeles
    Los Angeles, California 90027, United States
  • Southern California Permanente Medical Group
    Los Angeles, California 90027, United States
  • Valley Children's Hospital
    Madera, California 93636, United States
  • Children's Hospital of Orange County
    Orange, California 92868, United States
  • Lucile Salter Packard Children's Hospital at Stanford
    Palo Alto, California 94304, United States
  • Loma Linda University
    San Bernardino, California 92408, United States
  • UCSF Children's Hospital
    San Francisco, California 94143, United States
  • Colorado Children's Hospital
    Aurora, Colorado 80045, United States
  • Connecticut Children's Medical Center
    Hartford, Connecticut 06106, United States
  • Alfred I Dupont Hospital For Children
    Wilmington, Delaware 19803, United States
  • Children's Hospital National Medical Center
    Washington, District of Columbia 20010-2970, United States
  • Golisano Children's Hospital of Southwest Florida
    Fort Myers, Florida 33908, United States
  • Nemours Children's Clinic
    Jacksonville, Florida 32207, United States
  • All Children's Hospital
    Saint Petersburg, Florida 33701, United States
  • Children's Healthcare of Atlanta
    Atlanta, Georgia 30322, United States
  • Ann and Robert H Lurie Childrens Hospital of Chicago
    Chicago, Illinois 60611, United States
  • Advocate Chilldren's Hospital
    Oak Lawn, Illinois 60453, United States
  • Riley Hospital For Children at IU Health
    Indianapolis, Indiana 46202, United States
  • Kosair Children's Hospital
    Louisville, Kentucky 40202, United States
  • Children's Hospital New Orleans
    New Orleans, Louisiana 70118, United States
  • Johns Hopkins University
    Baltimore, Maryland 21287, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Children's Hospitals and Clinics of Minnesota
    Minneapolis, Minnesota 55404, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Children's Specialty Center of Nevada
    Las Vegas, Nevada 89109, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Morristown Memorial Hosp
    Morristown, New Jersey 07962, United States
  • Cancer Institute of New Jersey
    New Brunswick, New Jersey 08903, United States
  • Roswell Park Cancer Inst
    Buffalo, New York 14263, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
  • New York Medical College
    Valhalla, New York 10595, United States
  • University of North Carolina
    Chapel Hill, North Carolina 27599, United States
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
  • Legacy Emanuel Hospital and Health Center
    Portland, Oregon 97227, United States
  • Penn State Milton S Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • UPMC Childrens Hospital of Pittsburgh
    Pittsburgh, Pennsylvania 15224, United States
  • Carolinas Healthcare System
    Charleston, South Carolina 28203, United States
  • Greenville Health System
    Greenville, South Carolina 29605, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37212, United States
  • Dell Children's Medical Center of Central Texas
    Austin, Texas 78723, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75235, United States
  • Texas Children's Cancer Center
    Houston, Texas 77030, United States
  • Methodist Hospital
    San Antonio, Texas 78229, United States
  • Primary Children's Medical Center
    Salt Lake City, Utah 84113, United States
  • Children's Hospital of The King's Daughters
    Norfolk, Virginia 23507, United States
  • Seattle Children's Hospital
    Seattle, Washington 98105, United States
  • Midwest Children's Cancer Center
    Milwaukee, Wisconsin 53226, United States
  • Alberta Childrens Hospital
    Calgary, Alberta T3B 6A8, Canada
  • British Columbia Children's Hospital
    Vancouver, British Columbia V6H3V4, Canada
  • IWK Health Center
    Halifax, Nova Scotia B3K 6R8, Canada
  • Childrens Hospital of Eastern Ontario
    Ottawa, Ontario K1H 8L1, Canada
  • McGill University Health Center
    Montreal, Quebec H4A 3J1, Canada
  • Hospital For Sick Children
    Torento, M5G 1X8, Canada
09

References and documents

Publications

  • O'Brien MM, Alonzo TA, Cooper TM, Levine JE, Brown PA, Slone T, August KJ, Benettaib B, Biserna N, Poon J, Patturajan M, Chen N, Simcock M, Zimmerman L, Kolb EA. Results of a phase 2, multicenter, single-arm, open-label study of lenalidomide in pediatric patients with relapsed or refractory acute myeloid leukemia. Pediatr Blood Cancer. 2021 Jul;68(7):e28946. doi: 10.1002/pbc.28946. Epub 2021 Mar 10. PubMed 33694257 ↗

Study documents

  • Study protocol · Dec 13, 2016
  • Statistical analysis plan · Jan 2, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02538965
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Sep 2, 2015
Start date
Nov 19, 2015
Primary completion
Jul 22, 2017
Completion
Jan 11, 2019
Results posted
Sep 20, 2018
Last update
Jan 7, 2020

Study contacts

Bouchra Benettaib, MD
study director · Celgene Corporation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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