Open-label Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma (REvMM2009)
Recruitment status was Recruiting
Patients with cutaneous T cell lymphoma experience refractory and progressive disease despite current treatment, necessitating chronic disease management. In addition, there needs to be greater emphasis on combination treatment, which correlates with increased response rate, more rapid onset of response, and decreased side effect profile compared to monotherapy. The goal for the use of Lenalidomide as an adjuvant treatment in patients with refractory cutaneous T cell lymphoma is to increase response rates, maintain a durable long-term response, relieve associated symptoms, and minimize toxic side effects.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-label Phase 2 Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma|
- 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) ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Contact: Francisco A Kerdel, M.D.||305 324 email@example.com|
|United States, Florida|
|Florida Academic Dermatology Center||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Annika M Grant, RN,MBA 305-324-2110 ext 210 firstname.lastname@example.org|
|Principal Investigator: Francisco A Kerdel, M.D.|