Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, T-Cell, Cutaneous

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Lenalidomide Starting Dose Based on Renal Function at Study Entry Baseline Calculated Creatinine Clearance (by Cockcroft-Gault) Starting Lenalidomide Dose 60 ml/min 25mg daily on Days 1-21 of each 28-day cycle 30 and \< 60 ml/min 10mg daily on Days 1-21 of each 28-day cycle

Francisco A Kerdel, M.D.

Annika M Grant, RN,MBA

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.

Open-label Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma

Open-label Phase 2 Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma

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.

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 validated DLQI patient self assessment questionnaire will be used to quantify the impact of skin disease on patients' quality of life

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.

Celgene Corporation

Florida Academic Dermatology Centers

Francisco a Kerdel,M.D

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Open-label Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma	NCT01132989	Cutaneous T Cel...	Lenalidomide	18 Years -	Florida Academic Dermatology Centers
Open-label Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma	NCT01132989	Cutaneous T Cel...	Lenalidomide	18 Years -	Florida Academic Dermatology Centers

Spots Global Cancer Trial Database for patients with cutaneous t cell lymphoma