Status:
COMPLETED
Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Basophilic Leukemia
Adult Acute Eosinophilic Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE2
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 stimulat...
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 lenal...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00352365
Start Date
June 1 2006
End Date
July 1 2011
Last Update
February 11 2022
Active Locations (54)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Shasta Regional Medical Center
Redding, California, United States, 96001
3
Sutter Roseville Medical Center
Roseville, California, United States, 95661
4
Sutter General Hospital
Sacramento, California, United States, 95816