NCT00963105

Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

A Phase 2, Multi-Center, Randomized, Double-Blinded, Parallel Group Study of the Safety and Efficacy of Different Lenalidomide (REVLIMID®) Dose Regimens in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Conditions

• Relapsed or Refractory Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	lenalidomide	Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows: * Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily * Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily * Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity

Timeline

• Start date: 2009-10-19
• Primary completion: 2017-09-05
• Completion: 2017-09-05
• First posted: 2009-08-21
• Last updated: 2018-10-31
• Results posted: 2018-10-02

Locations

52 sites across 8 countries: United States, Canada, France, Germany, Italy, Spain, Sweden, United Kingdom