Acute Myeloid Leukemia Clinical Trial
Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
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.
Full 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 lenalidomide is sufficiently high to warrant a phase III investigation.
II. Estimate the frequency and severity of toxicities of this drug in these patients.
III. Correlate, in a preliminary manner, additional cytogenetic abnormalities with response to lenalidomide.
IV. Estimate the total (complete and partial) response rate and the cytogenetic response rate in these patients.
OUTLINE:
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.
After completion of study treatment, patients are followed periodically for up to 5 years.
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
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There are 43 Locations for this study
Little Rock Arkansas, 72205, United States
Redding California, 96001, United States
Roseville California, 95661, United States
Sacramento California, 95816, United States
Tampa Florida, 33612, United States
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Springfield Illinois, 62781, United States
Salina Kansas, 67401, United States
Ann Arbor Michigan, 48109, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59102, United States
Billings Montana, 59107, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Havre Montana, 59501, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59801, United States
Missoula Montana, 59802, United States
Missoula Montana, 59802, United States
Missoula Montana, 59804, United States
Rochester New York, 14623, United States
Rochester New York, 14642, United States
Cincinnati Ohio, 45267, United States
Independence Ohio, 44131, United States
Wooster Ohio, 44691, United States
Knoxville Tennessee, 37920, United States
Bellingham Washington, 98225, United States
Bremerton Washington, 98310, United States
Kennewick Washington, 99336, United States
Mount Vernon Washington, 98274, United States
Poulsbo Washington, 98370, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98109, United States
Seattle Washington, 98112, United States
Seattle Washington, 98122, United States
Seattle Washington, 98122, United States
Seattle Washington, 98195, United States
Sedro-Woolley Washington, 98284, United States
Spokane Washington, 99202, United States
Spokane Washington, 99218, United States
Wenatchee Washington, 98801, United States
Casper Wyoming, 82609, United States
Sheridan Wyoming, 82801, United States
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