Acute Myeloid Leukemia Clinical Trial
A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia
Summary
The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (AML).
Full Description
On September 11, 2013, randomization into the continuous 50 mg lenalidomide only arm was temporarily suspended based on review of the data from the first 13 participants and a high rate of discontinuation (11/13 participants). The Data Monitoring Committee assessed the study data on September 20, 2013 and reported no safety concerns. The high rate of early discontinuation is inconsistent with the treatment duration required for testing the study primary endpoint of survival at one year. Consequently, Celgene has decided not to reopen the lenalidomide only arm.
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder or therapy-related AML
Male or female subjects aged ≥ 65
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
White blood cell (WBC) count ≤ 10 x 10â¹/L at screening
Exclusion Criteria:
Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide
Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted therapy agents.
Suspected or proven acute promyelocytic leukemia
Prior bone marrow or stem cell transplantation
Candidate for allogeneic bone marrow or stem cell transplantation
AML antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms
Presence of malignant disease within the previous 12 months with exceptions
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There are 30 Locations for this study
Tucson Arizona, 85724, United States
La Jolla California, 92093, United States
Los Angeles California, 90048, United States
Orange California, 92868, United States
Sacramento California, 95857, United States
San Luis Obispo California, 93401, United States
Stanford California, 94305, United States
Aurora Colorado, 80045, United States
Miami Beach Florida, 33140, United States
Chicago Illinois, 60612, United States
Westwood Kansas, 66205, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, 70072, United States
Minneapolis Minnesota, 55455, United States
Saint Louis Missouri, 63110, United States
Billings Montana, 59101, United States
New York New York, 10029, United States
Pittsburgh Pennsylvania, 15224, United States
Greenville South Carolina, 29605, United States
Sioux Falls South Dakota, 57105, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75390, United States
San Antonio Texas, 78229, United States
Madison Wisconsin, 53792, United States
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Winnipeg Manitoba, R3E 0, Canada
Halifax Nova Scotia, B3H 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 2, Canada
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