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
Trial ID or NCT#
Status
Purpose
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).
Official Title
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
Eligibility 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
- * 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov