Lenalidomide (Revlimid®) as Second Line Therapy in Patients With Chronic Graft-Vs-Host Disease (GVHD)
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|ClinicalTrials.gov Identifier: NCT00675441|
Recruitment Status : Terminated (Terminated due to slow accrual.)
First Posted : May 9, 2008
Results First Posted : December 11, 2013
Last Update Posted : December 11, 2013
The goal of this clinical research study is to learn if Revlimid® (lenalidomide), along with standard-of-care steroid treatment you are already receiving, can help to control Chronic Graft-Versus-Host Disease (cGVHD). The safety of this study drug in combination with the steroids will also be studied.
- To assess the response rate of chronic GVHD to Lenalidomide after failing steroids
- To evaluate the safety and tolerability of Lenalidomide in patients with chronic GVHD
- To assess the steroid-sparing capacity of Lenalidomide (as proportion of patients able to discontinue steroids while receiving or following therapy with Lenalidomide)
- To assess changes in QOL after treatment with Lenalidomide
- To analyze survival at 6 and 12 months after initiation of Lenalidomide
- To evaluate relapse of underlying malignancy as well as second malignancies at 6 and 12 months after initiation of Lenalidomide
|Condition or disease||Intervention/treatment||Phase|
|Graft-versus-Host Disease||Drug: Lenalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Lenalidomide (Revlimid®) as Second Line Therapy in Patients With Chronic Graft-Versus-Host Disease (GVHD)|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
- Number of Participants' With Treatment Response of Complete or Partial Response [ Time Frame: Response assessed after completing 28 day cycle, repeated with each cycle for 6 cycles, approximately 180 days. ]Treatment responses defined as complete (CR) or partial organ response (PR) of chronic Graft-Versus-Host Disease (GVHD) to lenalidomide. Complete organ response (CR) indicates resolution of all reversible manifestations related to chronic GVHD in a specific organ. Partial organ response (PR) requires at least 50% improvement in scale used to measure disease manifestations related to chronic GVHD. Tools for response evaluation were skin assessment and functional assessment including minute walk and grip strength.
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): NCT00675441
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Amin Alousi, MD||M.D. Anderson Cancer Center|