Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia (NCT00352365) | Clinical Trial Compass
CompletedPhase 2
Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
United States41 participantsStarted 2006-06
Plain-language 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.
Who can participate
Age range60 Years
SexALL
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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…