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
Acute Myeloid Leukemia, Acute Myelogenous Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, elderly, acute myelogenous leukemia, vidaza, azacitidine, elderly AML, revlimid, lenalidomide
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 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
Sites / Locations
- (210) University of Arizona Cancer Center
- (180) University of California, San Diego
- (240) Cedars-Sinai Medical Center
- (215) Hematology Oncology Medical Group
- (130) UC Davis Medical Center
- (200) Coastal Integrative Cancer Care
- (125) University of Stanford
- (115) University of Colorado Anschultz Cancer Center
- (145) Mount Sinai Comprehensive Cancer Center
- (140) Rush University Medical Center
- (185) The University of Kansas Cancer Center
- (175) University Lousiville
- (195) Tulane University Hospital Tulane Cancer Center
- (235) University of Minnesota
- (100) Washington University School of Medicine
- (150) Billings Clinic
- (165) Mount Sinai Medical Center New York
- (160) The Western Pennsylvania Hospital- Cancer Institute
- (205) Greenville Hospital System
- (120) Avera Cancer Institute
- (230) Tennessee Oncology, PLLC
- (105) University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center
- (155) Cancer Care Centers of South Texas
- (135) University of Wisconsin
- (402) Tom Baker Cancer Centre
- (405) University of Alberta Hospital
- (401) Cancer Care Manitoba
- (403) Queen Elizabeth II Health Sciences Centre - VG Site
- (404) The Ottawa Hospital
- (400) Princess Margaret Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Lenalidomide in combination with azacitidine
Lenalidomide - single agent
Azacitidine-single agent
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
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
Repeated cycles of azacitidine 75mg/m^2/day subcutaneous on Days 1-7 followed by a 21-day break plus best supportive care