Study of Lenalidomide (Revlimid) in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL) Patients
Revlimid is a potent immunomodulatory analogue without the teratogenic effects, which has direct anti-tumor effects, anti-angiogenic and both anti-inflammatory and T-cell costimulatory properties. Both preclinical and clinical data indicate its efficacy solid tumor and multiple myeloma including advanced/refractory stages with its role in enhancing host antitumor immunity that provided the rationale to use in patients with PTCL.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- To assess the feasibility of Revlimid as salvage treatment in PTCL [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01036399
|Institute Of Hematology "Seràgnoli"|
|Bologna, Italy, 40138|