Open-label Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma (REvMM2009)
|ClinicalTrials.gov Identifier: NCT01132989|
Recruitment Status : Unknown
Verified May 2010 by Florida Academic Dermatology Centers.
Recruitment status was: Recruiting
First Posted : May 28, 2010
Last Update Posted : May 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous T Cell Lymphoma||Drug: Lenalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label Phase 2 Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2010|
- Response rate(RR measurements are based on skin scoring using mSWAT (modified severity weighted assessment tool), Sezary cell count, and lymph node assessment. [ Time Frame: 1 year (average) ]
The primary efficacy measure is the response rate (RR) based on skin scoring using mSWAT (modified severity weighted assessment tool), Sezary cell count, and lymph node assessment. Response rate is defined as the number of responders divided by the number of treated patients. A responder is defined as any patient who exhibits a confirmed complete or partial response.
• Patients will be treated until progressive disease is demonstrated by ≥ 25% increase of SWAT score.
- The assessment of patient-reported changes of pruritus during treatment [ Time Frame: 1 year (average) ]Descriptive statistics will be calculated for pruritus relief. Both median duration of pruritus relief (for those exhibiting improvement in pruritus) and time to pruritus relief will be estimated.
- The assessment of the patient-reported improvement in quality of life during treatment [ Time Frame: 1 year (average) ]The validated DLQI patient self assessment questionnaire will be used to quantify the impact of skin disease on patients' quality of life
- The assessment of the safety and tolerability of lenalidomide in the study population [ Time Frame: 1 year (average) ]The assessments of sezary cell count ,disease status using the mSWAT tool, lymphnode evaluations and adverse event incidences( associated with study medication )will be perfomed every four weeks to assess lenalidomide safety and tolerability.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132989
|Contact: Francisco A Kerdel, M.D.||305 324 firstname.lastname@example.org|
|United States, Florida|
|Florida Academic Dermatology Center||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Annika M Grant, RN,MBA 305-324-2110 ext 210 email@example.com|
|Principal Investigator: Francisco A Kerdel, M.D.|