Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

Completed · Phase 2

Conditions studied: Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT00352365

Run by

National Cancer Institute (NCI)

People needed

41

Starts

2006-06-01

Expected to finish

2011-07-01

Last updated by the study team

2022-02-11

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• 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
• Montana Cancer Consortium CCOP — Billings, Montana, United States
• Northern Rockies Radiation Oncology Center — Billings, Montana, United States
• Saint Vincent Healthcare — Billings, Montana, United States
• Hematology-Oncology Centers of the Northern Rockies PC — Billings, Montana, United States
• Billings Clinic — Billings, Montana, United States
• Deaconess Medical Center — Billings, Montana, United States
• Bozeman Deaconess Cancer Center — Bozeman, Montana, United States
• Bozeman Deaconess Hospital — Bozeman, Montana, United States
• Saint James Community Hospital and Cancer Treatment Center — Butte, Montana, United States
• Berdeaux, Donald MD (UIA Investigator) — Great Falls, Montana, United States
• Great Falls Clinic — Great Falls, Montana, United States
• Northern Montana Hospital — Havre, Montana, United States
• Saint Peter's Community Hospital — Helena, Montana, United States
• Glacier Oncology PLLC — Kalispell, Montana, United States
• Kalispell Medical Oncology — Kalispell, Montana, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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