Spots Global Cancer Trial Database for Safety And Efficacy Of Azacitidine, and Lenalidomide In Higher Risk Myelodysplastic Syndrome
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Trial Identification
Brief Title: Safety And Efficacy Of Azacitidine, and Lenalidomide In Higher Risk Myelodysplastic Syndrome
Official Title: A PHASE 2, SINGLE ARM STUDY TO DETERMINE THE SAFETY AND EFFICACY OF AZACITIDINE, AND LENALIDOMIDE IN HIGHER RISK MYELODYSPLASTIC SYNDROME
Study ID: NCT01053806
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of internal medicine A, Tel-Aviv, , Israel
Contact Details
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