Safety And Efficacy Of Azacitidine, and Lenalidomide In Higher Risk Myelodysplastic Syndrome (ViLen 001)
To evaluate the overall response rate of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients (INT-2 and High risk defined by IPSS), and patients with low and int-1 who are considered to be at high risk due to unfavorable additional factors.
- To evaluate the safety of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients.
- To evaluate the hematological improvement rate.
- To evaluate the cytogenetic response rate.
- To evaluate the Progression free survival (PFS).
- To assess Quality of life.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A PHASE 2, SINGLE ARM STUDY TO DETERMINE THE SAFETY AND EFFICACY OF AZACITIDINE, AND LENALIDOMIDE IN HIGHER RISK MYELODYSPLASTIC SYNDROME|
- ORR [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- PFS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Drug: 5-Azacytidine and Lenalidomide
|Contact: Moshe Mittelman, firstname.lastname@example.org|
|Department of internal medicine A||Recruiting|
|Contact: Moshe Mittelman, Prof email@example.com|
|Principal Investigator: Moshe Mittelman, Prof|