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

Celgene

Status and phase: Completed; Phase 2

Conditions: Acute Myelogenous Leukemia; Acute Myeloid Leukemia

Treatments: Drug: Azacitidine; Drug: Lenalidomide; Other: Best Supportive Care (BSC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01358734

CC-5013-AML-001

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 3 patient groups

Lenalidomide in combination with azacitidine

Experimental group

Description:

Repeated cycles of azacitidine 75 mg/m\^2/day subcutaneous (SC) on Days 1-7 and lenalidomide 50 mg/day by mouth (PO) on Days 8-28 followed by a 14-day break plus best supportive care

Treatment:

Drug: Lenalidomide

Drug: Azacitidine

Other: Best Supportive Care (BSC)

Lenalidomide - single agent

Experimental group

Description:

Lenalidomide 50 mg PO daily for 28 days for the first 2 cycles and lenalidomide 25 mg daily for 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg daily PO plus best supportive care

Treatment:

Drug: Lenalidomide

Other: Best Supportive Care (BSC)

Azacitidine-single agent

Experimental group

Description:

Repeated cycles of azacitidine 75mg/m\^2/day subcutaneous on Days 1-7 followed by a 21-day break plus best supportive care

Treatment:

Drug: Azacitidine

Other: Best Supportive Care (BSC)