Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

Phase 2

Completed

Conditions: Adult Acute Eosinophilic Leukemia
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Basophilic Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Erythroleukemia (M6a)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Interventions: Drug: lenalidomide

Registration Number: NCT00352365

Lead Sponsor: National Cancer Institute (NCI)

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

Inclusion Criteria

Morphologically confirmed diagnosis of acute myeloid leukemia (AML) by bone marrow aspiration and biopsy within the past 14 days
- Diagnostic biopsy within the past 28 days with marrow blast percentage ≥ 70% allowed provided no potentially antileukemic therapy was received after biopsy
Cytogenetic evidence of del (5q) abnormality by conventional karyotyping or fluorescence in situ hybridization (FISH)
Previously untreated disease
- Must have declined standard AML cytotoxic chemotherapy regimens
WBC ≤ 30,000/mm³
History of prior myelodysplastic syndromes (MDS) allowed
No acute promyelocytic leukemia (FAB M3)
No blastic transformation of chronic myelogenous leukemia
Zubrod performance status 0-2
Bilirubin ≤ 2.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, but not to liver dysfunction)
AST and ALT ≤ 3.5 times ULN
Creatinine ≤ 1.5 times ULN
HIV negative
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 forms of effective contraception at least 4 weeks prior to, during, and for 4 weeks after completion of study treatment
No known allergy to thalidomide
Concurrent enrollment on SWOG-S9910 allowed (for SWOG patients)
No prior systemic chemotherapy for acute leukemia except hydroxyurea
- Single-dose intrathecal chemotherapy allowed before or concurrently with induction chemotherapy
No prior AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support
Prior hematopoietic growth factors, thalidomide, arsenic trioxide, signal-transduction inhibitors, azacitidine, and low-dose cytarabine (i.e., < 100 mg/m²/day) for treatment of MDS allowed
At least 30 days since prior therapy for MDS (excluding growth factors)
No prior lenalidomide for MDS
At least 6 months since prior chemotherapy or radiotherapy for another malignancy
No concurrent therapy for another malignancy
Concurrent hormonal therapy allowed

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (lenalidomide)	lenalidomide	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.

Primary Outcome Measures

Name	Time	Method
Complete Response	Up to 5 years	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.

Secondary Outcome Measures

Name	Time	Method
Total Response	Up to 5 years	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.
Cytogenetic Abnormalities	Up to 5 years	Number of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders.
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Up to 5 years	Only adverse events that are possibly, probably or definitely related to study drug are reported.

Trial Locations

Locations (54): University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
Shasta Regional Medical Center
🇺🇸
Redding, California, United States
Sutter Roseville Medical Center
🇺🇸
Roseville, California, United States
Sutter General Hospital
🇺🇸
Sacramento, California, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸
Tampa, Florida, United States
Cancer Care Center of Decatur
🇺🇸
Decatur, Illinois, United States
Decatur Memorial Hospital
🇺🇸
Decatur, Illinois, United States
Memorial Medical Center
🇺🇸
Springfield, Illinois, United States
Salina Regional Health Center
🇺🇸
Salina, Kansas, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
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University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States