Lenalidomide Combined to Azacitidine in Intermediate-2 or High Risk MDS With Del 5q (GFM-AZA-REV-09)
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|ClinicalTrials.gov Identifier: NCT01088373|
Recruitment Status : Completed
First Posted : March 17, 2010
Last Update Posted : December 15, 2017
Higher risk MDS with del(5q) carry very poor prognosis, but show some response to azacitidine and Lenalidomide as single agents . The combination of Lenalidomide and Azacytidine is currently tested in non del 5q MDS patients. Preliminary results have been recently presented at ASH meeting (Sekeres et al, 2007).
Overall, the combination of Lenalidomide and Azacitidine is well-tolerated and early results suggest some efficacy in advanced MDS without del 5q.
In this trial, we will combine Lenalidomide to Azacytidine in higher risk MDS with del (5q).
Patients will receive azacitidine( 75mg/m2/day for 5 days every 28 days) combined to escalating doses of lenalidomide (starting at relatively low dose).
For patients in hematological CR, PR, HI or marrow CR after cycle 2 or 4, it is mandatory to continue on Azacitidine + Lenalidomide as long as there is no unacceptable toxicity or overt progression, with the schedule that yielded response.
In patient still responding after 52 weeks, the drug will continue to be supplied, and follow up until death will be continued in all patients.
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes||Drug: Azacitidine combined to Lenalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of the Efficacy and Safety of Lenalidomide Combined to Azacitidine in Intermediate-2 or High Risk MDS With Del 5q|
|Actual Study Start Date :||March 25, 2010|
|Actual Primary Completion Date :||July 25, 2016|
|Actual Study Completion Date :||July 25, 2016|
|Experimental: Azacitidine, Lenalidomide||
Drug: Azacitidine combined to Lenalidomide
Azacitidine: 75mg/m2/d for 5 days per cycle of 28 days. Lenalidomide: 5mg/day during 14 days for cohort 1. Lenalidomide: 5mg/day during 21 days for cohort 2. Lenalidomide: 10mg/day during 21 days for cohort 3.
- To identify the "safe most successful dose"(sMSD) that is the dose level where the probabilities of success is maximized across the dose levels and the toxicity rate is kept within acceptable boundaries. [ Time Frame: 2 and 4 months of treatment ]Briefly, dose limiting toxicity would be defined by having greater than 30% occurrence of unexpected grade III-IV hematological or non hematological toxicity. Efficacy would be defined as a response rate of 40% after 2 cycles. Overall, 49 patients will be included.
- response rate and safety [ Time Frame: 36 months ]
- response rate (according to IWG 2006 criteria) to the combination of lenalidomide and azacitidine in adult high and int 2 MDS with del 5q
- safety (particularly hematological toxicity) of the combination of Lenalidomide and azacitidine in int-2 and high risk MDS with del 5q .
- duration of response,
- progression to AML,
- and overall survival.
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): NCT01088373
|Principal Investigator:||Lionel ADES, MD||GFM|