Study of Lenalidomide (Revlimid) in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL) Patients
|ClinicalTrials.gov Identifier: NCT01036399|
Recruitment Status : Terminated (The EC withdrawn the approval becuase of possible conflicts of interests between our Institute and Supporter (Celgene))
First Posted : December 21, 2009
Last Update Posted : August 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Peripheral T-cell Lymphoma||Drug: Lenalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2011|
Oral Revlimid is initiated on day 1 of cycle 1at the dose of 25 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles.
After this induction phase, the CR, PR and SD will continue Revlimid with the same schedule for other 8 months.
Oral Lenalidomide is initiated on day 1 of cycle 1at the dose of 25 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles.
Other Name: Revlimid
- To assess the feasibility of Revlimid as salvage treatment in PTCL [ Time Frame: 12 months ]
- To assess the overall response rate (CR and PR) of PTCL receiving REVLIMID; To assess the Tumor Control Rate (TCR); To assess the duration of response; To assess the quality of life. [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01036399
|Institute Of Hematology "Seràgnoli"|
|Bologna, Italy, 40138|