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 Leuk

• Status: Completed
• Trial end date: 2018-05-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Azacitidine; Lenalidomide; Thalidomide

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 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