Lenalidomide + Plerixafor in Previously Treated Chronic Lymphocytic Leukemia (CLL)

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

In research studies, lenalidomide (also called Revlimid) has shown some response in chronic lymphocytic leukemia (CLL); however, responses are usually partial responses that occur after several months of taking the study drug. It is thought that by adding the drug plerixafor (also called Mozobil) responses may be improved and/or occur sooner.

The main purpose of this study is to determine the dose of plerixafor that is safe to use in combination with lenalidomide. The study will also look at the response rates of the combination of lenalidomide and plerixafor and the effect the study drugs have on CLL cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Rizzieri, MD
• Collaborators: Celgene Corporation; Genzyme, a Sanofi Company
• Treatments: JM 3100; Lenalidomide; Plerixafor; Rituximab; Thalidomide

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of chronic lymphocytic leukemia (CLL) or Small lymphocytic lymphoma (SLL) as established by the National Cancer Institute (NCI) Working Group Response Criteria (NCI 96 Criteria).

• Received one or more prior therapies for CLL.

• Subjects must have symptomatic disease requiring therapy as defined by the protocol.

• >/= 4 weeks from prior cancer therapy.

• Eastern Cooperative Oncology Group (ECOG) performance status of
• All study subjects must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

Exclusion Criteria:

• Prolymphocytic leukemia (PLL).

• Richter's (large cell) transformation.

• Prior allogeneic transplant within 12 months or prior allogeneic transplant > 12 months currently receiving immunosuppressants.

• Active autoimmune hemolytic anemia.

• Central nervous system (CNS) involvement.

• Chronic enteral corticosteroids > 10mg prednisone or equivalent.

• Evidence of laboratory tumor lysis syndrome (TLS) by Cairo-Bishop Definition of Tumor Lysis Syndrome

• Use of any other experimental drug or therapy within 28 days of baseline

• Major surgery within 28 days of baseline.

• Known hypersensitivity to thalidomide.

• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.

• Any prior use of lenalidomide.

• Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).