Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Fludarabine

Fludarabine phosphate

Lenalidomide

Dasatinib

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

dasatinib 70 mg po daily plus lenalidomide 2.5 md po daily

dasatinib will be started at 70mg/day po and lenalidomide will be started at 2.5mg/day po

dasatinib and lenalidomide

Darren Sigal, MD

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.

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.

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

Bristol-Myers Squibb

Celgene Corporation

Scripps Health

Principal Investigator

Spots Global Cancer Trial Database for dasatinib and lenalidomide