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


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)

Rondeep Brar
Rondeep Brar

Clinical Associate Professor, Medicine - Hematology

Lauren Maeda
Lauren Maeda

Clinical Associate Professor, Medicine - Oncology


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


drug: Azacitidine

drug: Lenalidomide

other: Best Supportive Care (BSC)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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