Revlimid® as Consolidation Treatment Chronic Lymphocytic Leukemia

• Status: Terminated
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether on course (6 cycles) of consolidation therapy with Revlimid can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL) in the bone marrow.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Kipps
• Collaborator: Celgene Corporation
• Treatments: Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Diagnosis of chronic lymphocytic leukemia:

• Previously treated patients of any age with a diagnosis of CLL with documented residual disease following therapy, but not meeting an indication for treatment based on current guidelines

• At least 2 months following previous CLL directed therapy

• ECOG performance status of less than or equal to 2 at study entry

• Laboratory test results within these ranges:

• Platelet count greater than or equal to 50 x 109/L

• CrCl >.60 ml/min

• Total bilirubin less than or equal to 1.5 mg/dL

• AST (SGOT) and ALT (SGPT) less than or equal to 2 x ULN

• Females of childbearing must adhere to strict guidelines and have negative pregnancy test prior to enrollment

• Understand and voluntarily sign an informed consent form.

• Age greater than or equal to 18 years at the time of signing the informed consent form.

• Able to adhere to the study visit schedule and other protocol requirements.

• Disease free of prior malignancies for greater than or equal to 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ" of the cervix or breast.

• All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

• Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin).

Exclusion Criteria:

• Known Hepatitis B Ag positive, Hepatitis C positive patients.

• Known HIV positive patients.

• Patients with uncontrolled Autoimmune Hemolytic Anemia (AIHA) or autoimmune thrombocytopenia (ITP)

• Patients with active fungal, bacterial, and/or viral infection

• Patients with known hypersensitivity to Revlimid or thalidomide

• Concurrent use of other anti-cancer agents or treatments

• Patients with history of deep venous thrombus or pulmonary embolism

• Patients who are at increased risk of thrombosis during treatment with Revlimid including those taking concurrent erythropoietin, darbepoetin or high-dose corticosteroids

• Inability to provide informed consent.

• Concurrent malignancy (excluding basal and squamous cell skin cancers).

• Pregnant or breast-feeding females. (Lactating females must agree not to breast feed while taking Revlimid).

• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

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

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

• Patients with a history of embolic events (e.g. TIA) from arrhythmia or peripheral arterial disease or of recent MI whether or not treated with anti-platelet drug.