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CompletedNCT01780662Updated Oct 28, 2021Results posted

Brentuximab Vedotin and Gemcitabine Hydrochloride in Treating Younger Patients With Relapsed or Refractory Hodgkin Lymphoma

A Phase 1/2 interventional study of Brentuximab Vedotin and Gemcitabine Hydrochloride in Recurrent Adult Hodgkin Lymphoma, Recurrent Childhood Hodgkin Lymphoma and Refractory Childhood Hodgkin Lymphoma, sponsored by National Cancer Institute (NCI). Completed at 116 sites in 2 countries. Open to participants aged 13 Months to 30 Years. Per ClinicalTrials.gov, last updated 2021-10-28.

Sponsored by National Cancer Institute (NCI) · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
13 Months to 30 Years
Sex
All
01

Study summary

This phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with gemcitabine hydrochloride and to see how well they work in treating younger patients with Hodgkin lymphoma that has returned or does not respond to treatment. Monoclonal antibodies, such as brentuximab vedotin, may find cancer cells and help kill them. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving brentuximab vedotin together with gemcitabine hydrochloride may kill more cancer cells.

Read the detailed description

PRIMARY OBJECTIVES:

I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose of brentuximab vedotin in combination with gemcitabine administered every three weeks to children with relapsed or primary refractory Hodgkin lymphoma (HL).

II. To define and describe the toxicities of brentuximab vedotin in combination with gemcitabine administered on this schedule.

III. To determine the complete response (CR) rate after treatment with four cycles of gemcitabine with brentuximab vedotin among patients with relapsed or refractory HL.

SECONDARY OBJECTIVES:

I. To preliminarily define the antitumor activity of brentuximab vedotin in combination with gemcitabine within the confines of a Phase 1 study.

II. To describe the overall response rate (ORR) after 4 cycles of therapy among patients with relapsed or refractory HL.

III. To describe the proportion of patients with HL able to mobilize an adequate yield of cluster of differentiation (CD) 34+ stem cells after gemcitabine with brentuximab vedotin.

IV. To describe the relationship between disease response among patients with HL and changes in thymus and activation-regulated chemokine (TARC) during treatment, and to determine if specific micro ribonucleic acid (miRNA) profiles correlate with response to treatment.

V. To describe the frequency of the Fc gamma receptor IIIa (FcγRIIIa)-158 valine (V)/phenylalanine (F) polymorphism among patients who experience pulmonary toxicity on this protocol.

OUTLINE: This is a phase I, dose-escalation study of brentuximab vedotin followed by a phase II study. (Phase I completed as of amendment 4)

Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant.

After completion of study treatment, patients are followed up at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months.

02

Conditions studied

  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Childhood Hodgkin Lymphoma
  • Refractory Childhood Hodgkin Lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 46 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

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

04

Who can participate

Ages eligible
13 Months to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must have had histologic verification of the malignancy at original diagnosis; patients must have histologic verification of recurrent Hodgkin disease at the time of relapse; no additional biopsy is required for patients with primary refractory disease (i.e. no prior CR)

  • PARTS A AND B: Patients with Hodgkin lymphoma (HL) are eligible for both the phase 1 and 2 portions, if they are in one of the following categories:

    • Primary refractory disease (i.e. no prior CR)
    • Very early relapse (\< 6 months from the end of initial therapy, including chemotherapy ± radiation)
    • Advanced stage (III or IV) at diagnosis who relapse less than one year from the end of initial therapy
    • Note that patients with low-stage disease (IA or IIA) at initial diagnosis, who were treated with radiation alone or fewer than four cycles of chemotherapy will NOT be eligible
  • Patients must have measurable disease, documented by clinical and radiographic criteria
  • Patients must have a life expectancy of >= 8 weeks (>= 56 days)
  • Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =\< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score

  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy

    • At least 14 days after the last dose of myelosuppressive chemotherapy (28 days if prior nitrosourea); Note: cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of therapy
    • At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair
    • At least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair
    • At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
    • At least 3 half-lives of the antibody after the last dose of a monoclonal antibody
    • At least 14 days after local palliative radiation therapy (XRT) (small port); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation
    • Patients with prior autologous or allogeneic stem cell transplant (SCT) are excluded from this study
    • At least 28 days must have elapsed since the most recent dose of bleomycin, to allow adequate time to detect evidence of bleomycin-related pulmonary toxicity
  • PART A: FOR PATIENTS WITH KNOWN BONE MARROW INVOLVEMENT (Completed as of Amendment 4)
  • Peripheral absolute neutrophil count (ANC) >= 1000/uL
  • Platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
  • PART B: FOR PATIENTS WITHOUT KNOWN BONE MARROW INVOLVEMENT
  • Peripheral absolute neutrophil count (ANC) >= 750/uL
  • Platelet count >= 75,000/uL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
  • Patients with lymphoma metastatic to bone marrow who have granulocytopenia, anemia, and/or thrombocytopenia will be eligible for study but not evaluable for hematologic toxicity (in Part A, there will be a maximum of one per cohort); such patients must meet the blood counts as in Part A (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled in Part A must be evaluable for hematologic toxicity
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m\^2 OR

  • A serum creatinine based on age/gender as follows:

    • =\< 0.6 mg/dL (for 1 to \< 2 years of age)
    • =\< 0.8 mg/dL (for 2 to \< 6 years of age)
    • =\< 1.0 mg/dL (for 6 to \< 10 years of age)
    • =\< 1.2 mg/dL (for 10 to \< 13 years of age)
    • =\< 1.4 mg/dL (for females >= 13 years of age)
    • =\< 1.5 mg/dL (for males 13 to \< 16 years of age)
    • =\< 1.7 mg/dL (for males >= 16 years of age)
  • Bilirubin (sum of conjugated + unconjugated) =\< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) \< 2.5 x upper limit of normal (ULN) for age; for the purpose of this study, the ULN for SGPT is 45 U/L
  • Serum albumin >= 2 g/dL
  • No evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry > 92% while breathing room air
  • Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from HL; carbon monoxide diffusion capacity (DLCO), FEV1, and forced vital capacity all > 50% predicted value; Note: pulmonary function testing is not required for children \< 8 years old, or for any child who is developmentally unable to comply with pulmonary function testing
  • Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
  • Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4) resulting from prior therapy must be \< grade 2

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during protocol therapy and for at least 30 days after the last dose of brentuximab vedotin; abstinence is an acceptable method of birth control

  • Concomitant medications

    • Patients receiving stable or decreasing corticosteroids are not eligible for other concurrent conditions (e.g. asthma, autoimmune diseases, rash, documented adrenal insufficiency) are eligible for this study
    • Patients who are currently receiving another investigational drug are not eligible
    • Patients who are currently receiving other anti-cancer agents are not eligible
  • Patients who have an uncontrolled infection are not eligible
  • Patients with an immunodeficiency that existed prior to diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible
  • Patients known to be positive for human immunodeficiency virus (HIV) are not eligible

  • Prior therapy

    • Patients with prior exposure to brentuximab vedotin are not eligible; NOTE: prior exposure to gemcitabine is NOT an exclusion criterion
    • Patients who have undergone prior autologous or allogeneic SCT are not eligible
    • Patients with HL who were stage IA or IIA at initial diagnosis and treated with either radiation alone or \< 4 cycles of chemotherapy are not eligible
  • Patients who have received a prior solid organ transplantation are not eligible
  • Patients with known hypersensitivity to Escherichia coli (E.coli)-derived proteins, filgrastim, or any component of filgrastim are not eligible
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Treatment (brentuximab vedotin, gemcitabine hydrochloride)

    Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant.

    Drug: Brentuximab Vedotin · Drug: Gemcitabine Hydrochloride

Interventions

  • DrugBrentuximab Vedotin

    Given IV

    Also known as: ADC SGN-35, Adcetris, Anti-CD30 Antibody-Drug Conjugate SGN-35, Anti-CD30 Monoclonal Antibody-MMAE SGN-35, Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35, cAC10-vcMMAE, SGN-35

  • DrugGemcitabine Hydrochloride

    Given IV

    Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, FF 10832, FF-10832, FF10832, Gemcitabine HCI, Gemzar, LY-188011, LY188011

06

What researchers measure

Primary outcomes

  1. Maximum Tolerated Dose (MTD) for Brentuximab Vedotin

    MTD was determined as the maximum dose at which fewer than one-third of patients experience Dose Limiting Toxicities (DLT) as assessed by National Cancer Institute (NCI) CTCAE v 4.0 during Cycle 1 of therapy. Gemcitabine was administered on days 1 and 8 of a 21 day cycle at a fixed dose. Brentuximab vedotin was investigated at a starting dose of 1.4 mg/kg administered on day 1 and escalated if tolerated.

    Time frame: During cycle 1 of protocol therapy (21 days)

  2. Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

    The number of eligible patients assigned to receive brentuximab vedotin in combination with gemcitabine that experienced CTC Version 4, grade 3 or higher adverse events during Phase 1 and Phase 2.

    Time frame: 13 months from first dose

  3. The Number of Patients With Relapsed or Refractory HL Who Achieved Complete Response (CR)

    The number of patients who experienced complete Response (CR) within the first four cycles. By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores \<=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.

    Time frame: After 4 cycles (21 days per cycle) of protocol therapy

Secondary outcomes

  1. The Number of Patients Who Had Disease Response Assessed by Deauville Scales Among Those in Phase I With Dose Level 2.

    The Deauville five-point scale was used to assess the number of participants with complete response (CR) and partial response (PR). A lower score indicates a better outcome. Scores of 1-3 represent CR and 4-5 represent PR.

    Time frame: Up to 13 months from first dose

  2. Percentage of Patients Who Achieved Overall Response (OR) as Measured by Complete Response (CR) and Partial Response (PR)

    The percentage of patients who experienced complete Response (CR) within the first four cycles.By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores \<=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.

    Time frame: After 4 cycles (21 days per cycle) of protocol therapy

  3. The Number of Patients Who Had Successful Peripheral Blood Stem Cell (PBSC) Collection

    Successful PBSC collection was defined as a collection of more than 2x10\^6 CD34 positive cells.

    Time frame: From 1 to 5 cycles

  4. Plasma Level of Thymus and Activation-Regulated Chemokine (TARC)

    Limit to 41 evaluable patients who received dose 1.8 mg/kg

    Time frame: From baseline to time prior to cycle 2

  5. Correlation Between Micro Ribonucleic Acid (miRNA) and Disease Response to Protocol Treatment

    Limit to 41 evaluable patients who received dose 1.8 mg/kg

    Time frame: From the end of first dose to the end of last dose (Up to 13 Months)

  6. Number of Patients With FcyRIIIa-158 V/F (Valine/Phenylalanine) Polymorphism

    Among patients who received 1.8mg/kg dose, the frequency of the FcγRIIIa-158 V/F polymorphism are described.

    Time frame: From the end of first dose to the end of last dose (Up to 13 Months)

07

Results

Posted Oct 1, 2019
Limitations and caveats
Samples have been banked, but data will never be analyzed for Outcome measure #8, Correlation between micro ribonucleic acid (miRNA) and disease response to protocol treatment.

Participant flow

Participant flow — Overall Study
MilestonePhase I, 1.4mg/kgPhase I, 1.8mg/kgPhase II, 1.8mg/kg
Started31330
Completed2720
Not completed1610
Withdrew: Adverse event102
Withdrew: Physician decision057
Withdrew: Protocol violation010
Withdrew: Ineligible001

Outcome measures

PrimaryMaximum Tolerated Dose (MTD) for Brentuximab Vedotin

MTD was determined as the maximum dose at which fewer than one-third of patients experience Dose Limiting Toxicities (DLT) as assessed by National Cancer Institute (NCI) CTCAE v 4.0 during Cycle 1 of therapy. Gemcitabine was administered on days 1 and 8 of a 21 day cycle at a fixed dose. Brentuximab vedotin was investigated at a starting dose of 1.4 mg/kg administered on day 1 and escalated if tolerated.

Time frame:
During cycle 1 of protocol therapy (21 days)
Reported as:
Number · mg/kg
Maximum Tolerated Dose (MTD) for Brentuximab Vedotin
mg/kgTreatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)
Maximum Tolerated Dose (MTD) for Brentuximab Vedotin1.8
PrimaryAdverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

The number of eligible patients assigned to receive brentuximab vedotin in combination with gemcitabine that experienced CTC Version 4, grade 3 or higher adverse events during Phase 1 and Phase 2.

Time frame:
13 months from first dose
Reported as:
Count of participants · Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
ParticipantsDose 1.4mg/kg (Phase I)Dose 1.8mg/kg (Phase I + Phase II)
Abdominal pain01
Adrenal insufficiency01
Alanine aminotransferase increased113
Anemia14
Anorexia01
Aspartate aminotransferase increased110
Dehydration01
Dental caries01
Diarrhea03
Febrile neutropenia02
GGT increased01
Hemolytic uremic syndrome01
Hypophosphatemia02
Hypotension04
Infections and infestations - Other- Specify01
Investigations - Other- Specify01
Lung infection02
Lymphocyte count decreased38
Myositis01
Nausea02
Neutrophil count decreased328
Non-cardiac chest pain01
Pain in extremity01
Pericardial effusion01
Platelet count decreased013
Pneumonitis10
Pruritus10
Rash maculo-papular03
Skin infection01
Urinary tract infection01
White blood cell decreased315
PrimaryThe Number of Patients With Relapsed or Refractory HL Who Achieved Complete Response (CR)

The number of patients who experienced complete Response (CR) within the first four cycles. By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores \<=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.

Time frame:
After 4 cycles (21 days per cycle) of protocol therapy
Reported as:
Count of participants · Participants
The Number of Patients With Relapsed or Refractory HL Who Achieved Complete Response (CR)
ParticipantsTreatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)
The Number of Patients With Relapsed or Refractory HL Who Achieved Complete Response (CR)28
SecondaryThe Number of Patients Who Had Disease Response Assessed by Deauville Scales Among Those in Phase I With Dose Level 2.

The Deauville five-point scale was used to assess the number of participants with complete response (CR) and partial response (PR). A lower score indicates a better outcome. Scores of 1-3 represent CR and 4-5 represent PR.

Time frame:
Up to 13 months from first dose
Reported as:
Count of participants · Participants
The Number of Patients Who Had Disease Response Assessed by Deauville Scales Among Those in Phase I With Dose Level 2.
ParticipantsTreatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)
The Number of Patients Who Had Disease Response Assessed by Deauville Scales Among Those in Phase I With Dose Level 2.8
SecondaryPercentage of Patients Who Achieved Overall Response (OR) as Measured by Complete Response (CR) and Partial Response (PR)

The percentage of patients who experienced complete Response (CR) within the first four cycles.By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores \<=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.

Time frame:
After 4 cycles (21 days per cycle) of protocol therapy
Reported as:
Number · percentage of participants
Percentage of Patients Who Achieved Overall Response (OR) as Measured by Complete Response (CR) and Partial Response (PR)
percentage of participantsTreatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)
Percentage of Patients Who Achieved Overall Response (OR) as Measured by Complete Response (CR) and Partial Response (PR)74 (58 to 86)
SecondaryThe Number of Patients Who Had Successful Peripheral Blood Stem Cell (PBSC) Collection

Successful PBSC collection was defined as a collection of more than 2x10\^6 CD34 positive cells.

Time frame:
From 1 to 5 cycles
Reported as:
Count of participants · Participants
The Number of Patients Who Had Successful Peripheral Blood Stem Cell (PBSC) Collection
ParticipantsTreatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)
The Number of Patients Who Had Successful Peripheral Blood Stem Cell (PBSC) Collection24
SecondaryPlasma Level of Thymus and Activation-Regulated Chemokine (TARC)

Limit to 41 evaluable patients who received dose 1.8 mg/kg

Time frame:
From baseline to time prior to cycle 2
Reported as:
Median · pg/ml
Plasma Level of Thymus and Activation-Regulated Chemokine (TARC)
pg/mlDose 1.8mg/kg
Baseline5700 (389 to 18,667)
Prior to Cycle 2668 (6 to 9,718)
SecondaryCorrelation Between Micro Ribonucleic Acid (miRNA) and Disease Response to Protocol Treatment

Limit to 41 evaluable patients who received dose 1.8 mg/kg

Time frame:
From the end of first dose to the end of last dose (Up to 13 Months)

No measurements were reported for this outcome.

SecondaryNumber of Patients With FcyRIIIa-158 V/F (Valine/Phenylalanine) Polymorphism

Among patients who received 1.8mg/kg dose, the frequency of the FcγRIIIa-158 V/F polymorphism are described.

Time frame:
From the end of first dose to the end of last dose (Up to 13 Months)
Reported as:
Count of participants · Participants
Number of Patients With FcyRIIIa-158 V/F (Valine/Phenylalanine) Polymorphism
ParticipantsDose 1.8mg/kg
Homozygous FF- Phenylalanine22
Heterozygous FV- Valine/Phenylalanine14
Homozygous VV- Valine5

Adverse events

Collected over From first dose up to 13 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dose1.4mg/kg2/3 (66.7%)3/3 (100%)3/3 (100%)
Dose 1.8mg/kg2/42 (4.8%)37/42 (88.1%)28/42 (66.7%)
Most frequent serious events
Showing 10 of 31
Most frequent serious events
EventDose1.4mg/kgDose 1.8mg/kg
Lymphocyte count decreasedInvestigations3/38/42
Neutrophil count decreasedInvestigations3/328/42
White blood cell decreasedInvestigations3/315/42
AnemiaBlood and lymphatic system disorders1/34/42
Alanine aminotransferase increasedInvestigations1/313/42
Aspartate aminotransferase increasedInvestigations1/310/42
PneumonitisRespiratory, thoracic and mediastinal disorders1/30/42
PruritusSkin and subcutaneous tissue disorders1/30/42
Platelet count decreasedInvestigations0/313/42
HypotensionVascular disorders0/34/42
Most frequent other events
Showing 10 of 100
Most frequent other events
EventDose1.4mg/kgDose 1.8mg/kg
NauseaGastrointestinal disorders3/39/42
Platelet count decreasedInvestigations3/35/42
VomitingGastrointestinal disorders2/38/42
FatigueGeneral disorders2/38/42
Alanine aminotransferase increasedInvestigations2/39/42
Aspartate aminotransferase increasedInvestigations2/310/42
Weight gainInvestigations2/30/42
AnorexiaMetabolism and nutrition disorders2/31/42
HeadacheNervous system disorders2/37/42
CoughRespiratory, thoracic and mediastinal disorders2/33/42

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Phase I Dose 1.4 mg/kgPhase I Dose 1.8 mg/kgPhase 2 Dose 1.8 mg/kgTotal
<=18 years3102437
Between 18 and 65 years0369
>=65 years0000
Sex: Female, Male
Sex: Female, Male(Participants)Phase I Dose 1.4 mg/kgPhase I Dose 1.8 mg/kgPhase 2 Dose 1.8 mg/kgTotal
Female181625
Male251421
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Phase I Dose 1.4 mg/kgPhase I Dose 1.8 mg/kgPhase 2 Dose 1.8 mg/kgTotal
Hispanic or Latino02911
Not Hispanic or Latino3112034
Unknown or Not Reported0011
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Phase I Dose 1.4 mg/kgPhase I Dose 1.8 mg/kgPhase 2 Dose 1.8 mg/kgTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0268
White3101932
More than one race0000
Unknown or Not Reported0156
Region of Enrollment
Region of Enrollment(Participants)Phase I Dose 1.4 mg/kgPhase I Dose 1.8 mg/kgPhase 2 Dose 1.8 mg/kgTotal
United States3132844
Canada0022
08

Study locations

116 sites
  • Children's Hospital of Alabama
    Birmingham, Alabama 35233, United States
  • Phoenix Childrens Hospital
    Phoenix, Arizona 85016, United States
  • Kaiser Permanente Downey Medical Center
    Downey, California 90242, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
  • Valley Children's Hospital
    Madera, California 93636, United States
  • UCSF Benioff Children's Hospital Oakland
    Oakland, California 94609, United States
  • Children's Hospital of Orange County
    Orange, California 92868, United States
  • Lucile Packard Children's Hospital Stanford University
    Palo Alto, California 94304, United States
  • Sutter Medical Center Sacramento
    Sacramento, California 95816, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • Rady Children's Hospital - San Diego
    San Diego, California 92123, United States
  • UCSF Medical Center-Mission Bay
    San Francisco, California 94158, United States
  • Children's Hospital Colorado
    Aurora, Colorado 80045, United States
  • Yale University
    New Haven, Connecticut 06520, United States
  • Alfred I duPont Hospital for Children
    Wilmington, Delaware 19803, United States
  • MedStar Georgetown University Hospital
    Washington, District of Columbia 20007, United States
  • Children's National Medical Center
    Washington, District of Columbia 20010, United States
  • Golisano Children's Hospital of Southwest Florida
    Fort Myers, Florida 33908, United States
  • University of Florida Health Science Center - Gainesville
    Gainesville, Florida 32610, United States
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
    Hollywood, Florida 33021, United States
  • Nemours Children's Clinic-Jacksonville
    Jacksonville, Florida 32207, United States
  • Nicklaus Children's Hospital
    Miami, Florida 33155, United States
  • AdventHealth Orlando
    Orlando, Florida 32803, United States
  • Arnold Palmer Hospital for Children
    Orlando, Florida 32806, United States
  • Nemours Children's Hospital
    Orlando, Florida 32827, United States
  • Nemours Children's Clinic - Pensacola
    Pensacola, Florida 32504, United States
  • Johns Hopkins All Children's Hospital
    Saint Petersburg, Florida 33701, United States
  • Saint Mary's Hospital
    West Palm Beach, Florida 33407, United States
  • Children's Healthcare of Atlanta - Egleston
    Atlanta, Georgia 30322, United States
  • Memorial Health University Medical Center
    Savannah, Georgia 31404, United States
  • Saint Luke's Cancer Institute - Boise
    Boise, Idaho 83712, United States
  • Lurie Children's Hospital-Chicago
    Chicago, Illinois 60611, United States
  • University of Illinois
    Chicago, Illinois 60612, United States
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
  • Saint Jude Midwest Affiliate
    Peoria, Illinois 61637, United States
  • Southern Illinois University School of Medicine
    Springfield, Illinois 62702, United States
  • Riley Hospital for Children
    Indianapolis, Indiana 46202, United States
  • Blank Children's Hospital
    Des Moines, Iowa 50309, United States
  • University of Kentucky/Markey Cancer Center
    Lexington, Kentucky 40536, United States
  • Ochsner Medical Center Jefferson
    New Orleans, Louisiana 70121, United States
  • Maine Children's Cancer Program
    Scarborough, Maine 04074, United States
  • Sinai Hospital of Baltimore
    Baltimore, Maryland 21215, United States
  • Johns Hopkins University/Sidney Kimmel Cancer Center
    Baltimore, Maryland 21287, United States
  • Massachusetts General Hospital Cancer Center
    Boston, Massachusetts 02114, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • Baystate Medical Center
    Springfield, Massachusetts 01199, United States
  • C S Mott Children's Hospital
    Ann Arbor, Michigan 48109, United States
  • Ascension Saint John Hospital
    Detroit, Michigan 48236, United States
  • Bronson Methodist Hospital
    Kalamazoo, Michigan 49007, United States
  • University of Minnesota/Masonic Cancer Center
    Minneapolis, Minnesota 55455, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
  • Children's Mercy Hospitals and Clinics
    Kansas City, Missouri 64108, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Sunrise Hospital and Medical Center
    Las Vegas, Nevada 89109, United States
  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
    Las Vegas, Nevada 89135, United States
  • Dartmouth Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Morristown Medical Center
    Morristown, New Jersey 07960, United States
  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
    New Brunswick, New Jersey 08903, United States
  • Newark Beth Israel Medical Center
    Newark, New Jersey 07112, United States
  • Saint Joseph's Regional Medical Center
    Paterson, New Jersey 07503, United States
  • Albany Medical Center
    Albany, New York 12208, United States
  • Montefiore Medical Center - Moses Campus
    Bronx, New York 10467, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
    New York, New York 10032, United States
  • NYP/Weill Cornell Medical Center
    New York, New York 10065, United States
  • University of Rochester
    Rochester, New York 14642, United States
  • Stony Brook University Medical Center
    Stony Brook, New York 11794, United States
  • State University of New York Upstate Medical University
    Syracuse, New York 13210, United States
  • New York Medical College
    Valhalla, New York 10595, United States
  • Carolinas Medical Center/Levine Cancer Institute
    Charlotte, North Carolina 28203, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • Sanford Broadway Medical Center
    Fargo, North Dakota 58122, United States
  • Children's Hospital Medical Center of Akron
    Akron, Ohio 44308, United States
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
  • Rainbow Babies and Childrens Hospital
    Cleveland, Ohio 44106, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
  • Dayton Children's Hospital
    Dayton, Ohio 45404, United States
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
  • Legacy Emanuel Children's Hospital
    Portland, Oregon 97227, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • Penn State Children's Hospital
    Hershey, Pennsylvania 17033, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
  • Saint Christopher's Hospital for Children
    Philadelphia, Pennsylvania 19134, United States
  • Children's Hospital of Pittsburgh of UPMC
    Pittsburgh, Pennsylvania 15224, United States
  • BI-LO Charities Children's Cancer Center
    Greenville, South Carolina 29605, United States
  • Sanford USD Medical Center - Sioux Falls
    Sioux Falls, South Dakota 57117-5134, United States
  • East Tennessee Childrens Hospital
    Knoxville, Tennessee 37916, United States
  • Saint Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
  • Vanderbilt University/Ingram Cancer Center
    Nashville, Tennessee 37232, United States
  • Dell Children's Medical Center of Central Texas
    Austin, Texas 78723, United States
  • Driscoll Children's Hospital
    Corpus Christi, Texas 78411, United States
  • UT Southwestern/Simmons Cancer Center-Dallas
    Dallas, Texas 75390, United States
  • Cook Children's Medical Center
    Fort Worth, Texas 76104, United States
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    Houston, Texas 77030, United States
  • Children's Hospital of San Antonio
    San Antonio, Texas 78207, United States
  • Methodist Children's Hospital of South Texas
    San Antonio, Texas 78229, United States
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States

Showing the first 100 of 116 sites across 2 countries.

09

References and documents

Publications

  • Cole PD, McCarten KM, Pei Q, Spira M, Metzger ML, Drachtman RA, Horton TM, Bush R, Blaney SM, Weigel BJ, Kelly KM. Brentuximab vedotin with gemcitabine for paediatric and young adult patients with relapsed or refractory Hodgkin's lymphoma (AHOD1221): a Children's Oncology Group, multicentre single-arm, phase 1-2 trial. Lancet Oncol. 2018 Sep;19(9):1229-1238. doi: 10.1016/S1470-2045(18)30426-1. Epub 2018 Aug 16. PubMed 30122620 ↗

Study documents

  • Protocol and statistical analysis plan · Nov 18, 2015

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 Oct 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01780662
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 31, 2013
Start date
Jan 31, 2013
Primary completion
Sep 30, 2017
Completion
Sep 30, 2021
Results posted
Oct 1, 2019
Last update
Oct 28, 2021

Study contacts

Peter D Cole
principal investigator · Children's Oncology Group

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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