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



Status:Completed
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:65 - Any
Updated:11/18/2018
Start Date:April 27, 2012
End Date:May 15, 2018

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A Phase 2, Multicenter, Randomized, Open-label, Parallel-group Study of a Lenalidomide (Revlimid®) Regimen or a Sequential Azacitidine (Vidaza®) Plus Lenalidomide (Revlimid®) Regimen Versus an Azacitidine (Vidaza®) Regimen for Therapy of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia

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).

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.

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 10⁹/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
We found this trial at
25
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Stanford, California 94305
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Stanford, CA
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Aurora, CO
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Billings, Montana 59101
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Billings, MT
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Calgary,
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Chicago, Illinois 60612
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Chicago, IL
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Dallas, TX
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Greenville, South Carolina 29605
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La Jolla, California 92093
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La Jolla, CA
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Los Angeles, California 90048
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Louisville, Kentucky 40202
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Madison, Wisconsin 53792
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Miami Beach, FL
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Minneapolis, Minnesota 55455
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Nashville, Tennessee 37203
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New Orleans, LA
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Orange, California 92868
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Orange, CA
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Pittsburgh, PA
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Sacramento, California 95857
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620 South Taylor Avenue
Saint Louis, Missouri 63110
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San Antonio, Texas 78229
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San Luis Obispo, California 93401
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Sioux Falls, South Dakota 57105
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Tucson, AZ
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Westwood, KS
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