Clinical Trial: Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase I/II Study of Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

Brief Summary: In a phase I study the investigators plan to investigate safety and toxicity of lenalidomide in patients with Chronic Myelomonocytic Leukemia (CMML). A phase II study will be started once an optimal dose has been found. The primary endpoint will concern the efficacy of lenalidomide in patients with CMML according to the WHO diagnostic criteria.

Detailed Summary:
Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

Current Primary Outcome: Maximum tolerated dose (MTD) [ Time Frame: 2 years ]

This is a phase I/II, open-label, dose-escalation study of lenalidomide in patients with CMML. In phase I of the study the primary purpose is to determine the MTD. The purpose of phase II is to determine the response rate.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number and seriousness of adverse events to evaluate safety and tolerability [ Time Frame: 4 years ]
    For both phases (phase I and II), secondary objectives are to evaluate safety, tolerability, efficacy and analysis of molecular markers.
  • Number of patients achieving transfusion independence [ Time Frame: 4 years ]
    Phase II
  • Progression free survival, Overall survival [ Time Frame: 4 years ]
    Phase II
  • Patients achieving cytogenetic response [ Time Frame: 4 years ]
    Phase II; Cytogenetic response assessment requires 20 analyzable metaphases using conventional cytogenetic techniques, FISH may be used an a supplement to follow a specifically defined cytogenetic abnormality


Original Secondary Outcome: Same as current

Information By: Arbeitsgemeinschaft medikamentoese Tumortherapie

Dates:
Date Received: May 9, 2011
Date Started: June 2010
Date Completion: May 2015
Last Updated: March 6, 2015
Last Verified: March 2015