Summary

for people ages 65 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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

Details

On September 11, 2013, randomization into the continuous 50 mg lenalidomide only arm was temporarily suspended based on review of the data from the first 13 participants and a high rate of discontinuation (11/13 participants). The Data Monitoring Committee assessed the study data on September 20, 2013 and reported no safety concerns. The high rate of early discontinuation is inconsistent with the treatment duration required for testing the study primary endpoint of survival at one year. Consequently, Celgene has decided not to reopen the lenalidomide only arm.

Keywords

Acute Myeloid Leukemia Acute Myelogenous Leukemia AML elderly vidaza azacitidine elderly AML revlimid lenalidomide Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Thalidomide Best Supportive Care (BSC) Lenalidomide - single agent Azacitidine-single agent

Eligibility

You can join if…

Open to people ages 65 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • (180) University of California, San Diego
    La Jolla California 92093-0960 United States
  • (215) Hematology Oncology Medical Group
    Orange California 92868 United States
  • (240) Cedars-Sinai Medical Center
    Los Angeles California 90048 United States
  • (200) Coastal Integrative Cancer Care
    San Luis Obispo California 93401 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT01358734
Phase
Phase 2
Study Type
Interventional
Last Updated
March 5, 2018