Safety And Efficacy Of Azacitidine, and Lenalidomide In Higher Risk Myelodysplastic Syndrome (ViLen 001)
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|ClinicalTrials.gov Identifier: NCT01053806|
Recruitment Status : Unknown
Verified September 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Recruiting
First Posted : January 21, 2010
Last Update Posted : September 25, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome||Drug: 5-Azacytidine and Lenalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PHASE 2, SINGLE ARM STUDY TO DETERMINE THE SAFETY AND EFFICACY OF AZACITIDINE, AND LENALIDOMIDE IN HIGHER RISK MYELODYSPLASTIC SYNDROME|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||March 2014|
Drug: 5-Azacytidine and Lenalidomide
- ORR [ Time Frame: 2 years ]
- PFS [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053806
|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|