Clinical Trial: Lenalidomide in Patients With Chronic Myelomonocytic Leukemia
Study Status: Completed
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 ]
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