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#

NCT01358734

Status

not recruiting iconNOT RECRUITING

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

Ages Eligible for Study: Older than 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Rondeep Brar
Rondeep Brar
Hematologist-Oncologist
Clinical Associate Professor, Medicine - Hematology
Lauren Maeda
Lauren Maeda
Hematologist, Lymphoma specialist, Hematologist-Oncologist
Clinical Associate Professor, Medicine - Oncology

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov