Lenalidomide After Failure of Hypomethylating Agents in Myelodysplastic Syndrome (VIOLET)
This is a Phase II study to evaluate the efficacy of second-line lenalidomide monotherapy for myelodysplastic syndrome (MDS) patients who failed to hypomethylating agents.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Salvage in Patients With Myelodysplastic Syndrome After Failure of Hypomethylating Agents: Lenalidomide as a Second-line Therapy|
- Response criteria by international working group (IWG) 2006 criteria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Safety assessed by national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 4.03
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment arm
Lenalidomide treatment arm
Lenalidomide 10 mg orally on days 1 to 21 of a 28-day cycle for at least 4 cycles until intolerance or disease progression.
Other Name: Revlimid
There is no standard therapy after the failure of hypomethylating agents only providing supportive cares including transfusion or cytokine therapies. Lenalidomide is the treatment of choice in case of MDS with 5q deletion. A study of lenalidomide for non-5q deletion MDS patients showed that transfusion independency rate was 26% which was relatively acceptable and suggested that lenalidomide could be used for non-5q deletion MDS patients. There is no datum for second-line lenalidomide therapy after hypomethylating agents. MDS which has highly complex pathogenesis backgrounds will have distinctive subtype for each therapy and each treatment drug can have distinctive subgroup for the response. In fact the investigators don't know which patient will be responsive hypomethylating agents or lenalidomide except for 5q deletion. This suggests that second line therapy after the first line failure in MDS will be different with other type of relapsed/refractory disease which will be tend to more resistant to subsequent therapies. In this regard, there is a possibility to have a relatively high response rate to second line lenalidomide in this selected subset who has failed to the hypomethylation therapy or some patients will be responsive regardless of treatment line. Recent data suggested that MDS with JAK2 mutation will be responsive to lenalidomide. The investigators will analyze the JAK2 mutation status in response evaluation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673308
|Korea, Republic of|
|Ulsan University Hospital|
|Ulsan, Korea, Republic of, 682714|
|Principal Investigator:||Hawk Kim, M.D., Ph.D.||Ulsan University Hospital, University of Ulsan College of Medicine|