Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Lenalidomide; Thalidomide

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