A Phase 2 interventional study of lenalidomide in Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia and Adult Acute Megakaryoblastic Leukemia (M7), sponsored by National Cancer Institute (NCI). Completed at 54 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2022-02-11.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.
PRIMARY OBJECTIVES:
I. Test whether the complete response rate among older patients with previously untreated acute myeloid leukemia (AML) with the del (5q) cytogenetic abnormality treated with lenalidomide is sufficiently high to warrant a phase III investigation.
II. Estimate the frequency and severity of toxicities of this drug in these patients.
III. Correlate, in a preliminary manner, additional cytogenetic abnormalities with response to lenalidomide.
IV. Estimate the total (complete and partial) response rate and the cytogenetic response rate in these patients.
OUTLINE:
INDUCTION THERAPY: Patients receive oral lenalidomide once daily on days 1-14, 1-21, or 1-28 (course 1). Patients undergo bone marrow biopsy on day 28 or 35 to assess treatment efficacy. Patients with stable or improving disease (i.e., a decrease in blast percentage) without progressive disease proceed to maintenance therapy.
MAINTENANCE THERAPY: Beginning within 42 days after completion of induction therapy, patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 41 is close to the median of 38 across 4,247 interventional studies indexed under Leukemia.
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Inclusion Criteria:
Morphologically confirmed diagnosis of acute myeloid leukemia (AML) by bone marrow aspiration and biopsy within the past 14 days
Previously untreated disease
No prior systemic chemotherapy for acute leukemia except hydroxyurea
INDUCTION THERAPY: Patients receive oral lenalidomide once daily on days 1-14, 1-21, or 1-28 (course 1). Patients undergo bone marrow biopsy on day 28 or 35 to assess treatment efficacy. Patients with stable or improving disease (i.e., a decrease in blast percentage) without progressive disease proceed to maintenance therapy. MAINTENANCE THERAPY: Beginning within 42 days after completion of induction therapy, patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: lenalidomide
Given orally
Also known as: CC-5013, IMiD-1, Revlimid
Complete Response
Morphologic complete remission (CR): ANC \>=1,000/mcl, platelet count \>=100,000/mcl, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcl and/or platelet count \<100,000/mcl.
Time frame: Up to 5 years
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time frame: Up to 5 years
Cytogenetic Abnormalities
Number of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders.
Time frame: Up to 5 years
Total Response
Morphologic complete remission (CR): ANC \>=1,000/mcl, platelet count \>=100,000/mcl, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcl and/or platelet count \<100,000/mcl. Partial remission (PR): ANC \>1,000/mcl, platelet count \>100,000/mcl, and at least 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts \<5% with persistent Auer rods.
Time frame: Up to 5 years
| Milestone | Lenalidomide |
|---|---|
| Started | 41 |
| Eligible | 38 |
| Eligible and began protocol therapy | 37 |
| Completed | 14 |
| Not completed | 27 |
| Withdrew: Adverse event | 7 |
| Withdrew: Progression/relapse | 8 |
| Withdrew: Death | 7 |
| Withdrew: Not protocol specified | 1 |
| Withdrew: Not eligible | 3 |
| Withdrew: Death before starting protocol therapy | 1 |
| Milestone | Lenalidomide |
|---|---|
| Started | 12 |
| Eligible and began protocol therapy | 8 |
| Completed | 0 |
| Not completed | 12 |
| Withdrew: Progression/relapse | 3 |
| Withdrew: Death | 2 |
| Withdrew: Not protocol specified | 3 |
| Withdrew: Not eligible | 4 |
Only adverse events that are possibly, probably or definitely related to study drug are reported.
| Participants | Induction Therapy | Maintenance Therapy |
|---|---|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | 1 | 0 |
| AST, SGOT | 1 | 0 |
| Adult respiratory distress syndrome (ARDS) | 1 | 0 |
| Anorexia | 1 | 0 |
| Bilirubin (hyperbilirubinemia) | 1 | 0 |
| Calcium, serum-low (hypocalcemia) | 3 | 0 |
| Cardiac-ischemia/infarction | 1 | 0 |
| Cough | 1 | 0 |
| Creatinine | 3 | 0 |
| Dermatology/Skin-Other (Specify) | 1 | 0 |
| Diarrhea | 2 | 0 |
| Dyspnea (shortness of breath) | 2 | 0 |
| Fatigue (asthenia, lethargy, malaise) | 11 | 0 |
| Febrile neutropenia | 15 | 2 |
| Glucose, serum-high (hyperglycemia) | 2 | 0 |
| Hemoglobin | 7 | 2 |
| Induration/fibrosis (skin and subcutaneous tissue) | 0 | 1 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Esophagus | 1 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Lip/perioral | 1 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 5 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums | 1 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 1 | 0 |
| Inf w/normal ANC or Gr 1-2 neutrophils - Blood | 0 | 1 |
| Leukocytes (total WBC) | 14 | 4 |
| Lymphopenia | 2 | 0 |
| Muscle weakness, not d/t neuropathy - body/general | 3 | 0 |
| Nausea | 1 | 0 |
| Neuropathy: motor | 1 | 0 |
| Neutrophils/granulocytes (ANC/AGC) | 16 | 5 |
| Platelets | 21 | 3 |
| Pneumonitis/pulmonary infiltrates | 4 | 0 |
| Potassium, serum-low (hypokalemia) | 3 | 0 |
| Pulmonary/Upper Respiratory-Other (Specify) | 2 | 0 |
| Rash/desquamation | 2 | 0 |
| Renal failure | 1 | 0 |
| Sodium, serum-high (hypernatremia) | 1 | 0 |
| Sodium, serum-low (hyponatremia) | 1 | 1 |
| Vomiting | 1 | 0 |
Number of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders.
| Number of abnormalities | Responders | Nonresponders |
|---|---|---|
| Cytogenetic Abnormalities | 8 (1 to 20) | 8 (0 to 31) |
Morphologic complete remission (CR): ANC \>=1,000/mcl, platelet count \>=100,000/mcl, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcl and/or platelet count \<100,000/mcl. Partial remission (PR): ANC \>1,000/mcl, platelet count \>100,000/mcl, and at least 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts \<5% with persistent Auer rods.
| percentage of participants | Induction Therapy |
|---|---|
| Total Response | 14 (5 to 29) |
Morphologic complete remission (CR): ANC \>=1,000/mcl, platelet count \>=100,000/mcl, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcl and/or platelet count \<100,000/mcl.
| percentage of participants | Induction Therapy |
|---|---|
| Complete Response | 11 (3 to 25) |
Collected over Up to 5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Induction Therapy | — | 24/37 (64.9%) | 34/37 (91.9%) |
| Maintenance Therapy | — | 4/8 (50%) | 8/8 (100%) |
| Event | Induction Therapy | Maintenance Therapy |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 5/37 | 2/8 |
| Death - Disease progression NOSNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 8/37 | 1/8 |
| Hemorrhage, GI - ColonGastrointestinal disorders | 0/37 | 1/8 |
| Inf w/normal ANC or Gr 1-2 neutrophils - BloodInfections and infestations | 1/37 | 1/8 |
| Leukocytes (total WBC)Investigations | 0/37 | 1/8 |
| PlateletsInvestigations | 3/37 | 1/8 |
| Pain - BackMusculoskeletal and connective tissue disorders | 0/37 | 1/8 |
| Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders | 3/37 | 1/8 |
| Induration/fibrosis (skin and subcutaneous tissue)Skin and subcutaneous tissue disorders | 0/37 | 1/8 |
| Fatigue (asthenia, lethargy, malaise)General disorders | 3/37 | 0/8 |
| Event | Induction Therapy | Maintenance Therapy |
|---|---|---|
| PlateletsInvestigations | 24/37 | 5/8 |
| HemoglobinBlood and lymphatic system disorders | 23/37 | 5/8 |
| Fatigue (asthenia, lethargy, malaise)General disorders | 18/37 | 5/8 |
| Leukocytes (total WBC)Investigations | 20/37 | 5/8 |
| Neutrophils/granulocytes (ANC/AGC)Investigations | 20/37 | 5/8 |
| Glucose, serum-high (hyperglycemia)Metabolism and nutrition disorders | 15/37 | 2/8 |
| Febrile neutropeniaBlood and lymphatic system disorders | 11/37 | 0/8 |
| Calcium, serum-low (hypocalcemia)Metabolism and nutrition disorders | 11/37 | 2/8 |
| DiarrheaGastrointestinal disorders | 8/37 | 2/8 |
| VomitingGastrointestinal disorders | 3/37 | 2/8 |
Eligible patients who began protocol therapy
| Age, Continuous(years) | Induction Therapy |
|---|---|
| Median | 73.7 (60.1 to 94) |
| Sex: Female, Male(Participants) | Induction Therapy |
|---|---|
| Female | 21 |
| Male | 16 |
| Race/Ethnicity, Customized(participants) | Induction Therapy |
|---|---|
| Black or African American | 3 |
| White | 33 |
| Unknown or Not Reported | 1 |
| Hispanic(participants) | Induction Therapy |
|---|---|
| Yes | 1 |
| No | 32 |
| Unknown | 4 |
| Disease Onset(participants) | Induction Therapy |
|---|---|
| De Novo | 16 |
| Treatment related | 2 |
| MDS related | 19 |
| Performance Status(participants) | Induction Therapy |
|---|---|
| 0 | 7 |
| 1 | 30 |
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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