NCT00829647

A Study Using Two Oral Chemotherapy Agents for Chronic Lymphocytic Leukemia

A Phase I/II Study of Combination Dasatinib and Lenalidomide in Purine Analogue-Failed Chronic Lymphocytic Leukemia

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Scripps Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Dasatinib and lenalidomide are both prescribed for use in patients with different cancers of the blood. This study is experimental because neither drug has been approved by the Food and Drug Administration for the treatment of chronic lymphocytic leukemia. There are few standard treatments when fludarabine is no longer effective in patients with CLL. Some patients have received additional combination therapy with fludarabine, Campath, bone marrow transplants or supportive care. Dasatinib and lenalidomide have been effective in high-risk CLL patients in other pilot mono therapy studies. The combination of dasatinib and lenalidomide has not been studied in humans before and this study is designed to test whether this combination is safe to use.

Detailed description

CLL is an incurable disease with current therapies. Modern chemoimmunotherapies, including combinations of rituximab and purine nucleoside analogues (fludarabine, cladribine, and pentostatin), offer the possibility for improved survival, but all patients will eventually relapse. Patients with relapsed or refractory disease will only experience diminishing benefits with additional lines of therapy. In addition, patients with high-risk CLL have poor responses to even first-line therapies. Lenalidomide and dasatinib have non-overlapping proposed mechanisms of action. Single agent phase II studies with lenalidomide and dasatinib have demonstrated responses in heavily pretreated and high-risk patients. For these reasons, we propose to treat patients with relapsed and/or refractory CLL to purine nucleoside analogue therapy with combination lenalidomide and dasatinib.

Conditions

• Chronic Lymphocytic Leukemia
• Leukemia

Interventions

Type	Name	Description
DRUG	dasatinib and lenalidomide	dasatinib will be started at 70mg/day po and lenalidomide will be started at 2.5mg/day po

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-12-01
• Completion: 2016-03-01
• First posted: 2009-01-27
• Last updated: 2019-04-11