©2025 Stanford Medicine
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
Not Recruiting
Trial ID: NCT01358734
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
Stanford Investigator(s)
Lauren Maeda
Clinical Associate Professor, Medicine - Oncology
Rondeep Brar
Clinical Professor, Medicine - Hematology
Eligibility
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
Intervention(s):
drug: Azacitidine
drug: Lenalidomide
other: Best Supportive Care (BSC)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061