Lenalidomide Maintenance Therapy Post Autologous Transplant for Hodgkins Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01207921|
Recruitment Status : Active, not recruiting
First Posted : September 23, 2010
Last Update Posted : June 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Disease||Drug: Lenalidomide||Phase 1|
-To evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after autologous stem cell transplant, as measured by dropout rate.
- To assess overall survival, event free survival, and progression free survival.
- To establish the adverse event profile of long-term maintenance therapy with lenalidomide in this patient population.
- To assess the conversion of partial response/stable disease post-ASCT to complete response.
- To evaluate changes in immune cell number and function and plasma proteins before, during, and after lenalidomide therapy (correlative studies).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplantation in Patients With Relapsed/Refractory Hodgkin Lymphoma|
|Actual Study Start Date :||April 28, 2011|
|Actual Primary Completion Date :||September 19, 2016|
|Estimated Study Completion Date :||October 31, 2018|
Experimental: Arm 1
Lenalidomide 15 mg/day Cycle 1 (28 days).
If no unacceptable side effects Cycle 2 (28 days) will be lenalidomide 20 mg/day.
If no unacceptable side effects Cycles 3 thru 18 (28 days for each cycle) will be lenalidomide 25 mg/day.
Other Name: Revlimid
- To evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after ASCT, as measured by dropout rate. [ Time Frame: 12 months ]Will be described by the proportion of patients who drop out of the study for drug-related reasons at or before 12 months
- Overall survival (OS) [ Time Frame: 13 months ]
- Adverse event profile [ Time Frame: From start of treatment through 30 days following completion of treatment ]To establish the adverse event profile of long-term maintenance therapy with lenalidomide in this patient population.
- Conversion of partial response/stable disease post-ASCT to complete response. [ Time Frame: 1 year ]To assess the conversion of partial response/stable disease post-autologous stem cell transplant to complete response.
- Evaluate immune response [ Time Frame: Through 30 days after end of treatment ]To evaluate changes in immune cell number and function and plasma proteins before, during, and after lenalidomide therapy (correlative studies).
- Event-free survival (EFS) [ Time Frame: 13 months ]
- Progression-free survival (PFS) [ Time Frame: 13 months ]
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): NCT01207921
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Wake Forest University|
|Winston-Salem, North Carolina, United States, 27106|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Todd Fehniger, M.D., Ph.D.||Washington University School of Medicine|