NCT01132989

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Florida Academic Dermatology Centers · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cutaneous T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Lenalidomide	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

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-05-28
• Last updated: 2010-05-28

Locations

1 site across 1 country: United States