Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7)
About this trial
This is an interventional treatment trial for Adult Acute Basophilic Leukemia
Eligibility Criteria
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
Sites / Locations
- University of Arkansas for Medical Sciences
- Shasta Regional Medical Center
- Sutter Roseville Medical Center
- Sutter General Hospital
- H. Lee Moffitt Cancer Center and Research Institute
- Cancer Care Center of Decatur
- Decatur Memorial Hospital
- Memorial Medical Center
- Salina Regional Health Center
- University of Michigan
- Montana Cancer Consortium CCOP
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Hematology-Oncology Centers of the Northern Rockies PC
- Billings Clinic
- Deaconess Medical Center
- Bozeman Deaconess Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Hospital
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Guardian Oncology and Center for Wellness
- Interlakes Foundation Inc-Rochester
- University of Rochester
- University of Cincinnati
- Cleveland Clinic Cancer Center Independence
- Cleveland Clinic Wooster Specialty Center
- University of Tennessee - Knoxville
- PeaceHealth Saint Joseph Medical Center
- Harrison Bremerton Hematology and Oncology
- Columbia Basin Hematology and Oncology PLLC
- Skagit Valley Hospital
- Harrison Poulsbo Hematology and Oncology
- Harborview Medical Center
- Minor and James Medical PLLC
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- Group Health Cooperative
- Swedish Medical Center-First Hill
- The Polyclinic
- University of Washington Medical Center
- United General Hospital
- Cancer Care Northwest - Spokane South
- Evergreen Hematology and Oncology PS
- Wenatchee Valley Medical Center
- Rocky Mountain Oncology
- Welch Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (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.