Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic Leukemia

• Status: Withdrawn
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II clinical trial is studying how well lenalidomide works in treating patients with high-risk chronic lymphocytic leukemia. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Definitive diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria

• Must have high-risk B-CLL as defined by ≥ one of the following:

• High-risk cytogenetics (either 17p deletion and/or 11q deletion)

• Unmutated immunoglobulin heavy chain gene rearrangement

• Zap-70 and CD38 expression on leukemic cells will not be used as eligibility criteria for enrollment into the clinical trial

• No prior treatment for the management of B-CLL

• Patients must have B-CLL requiring therapy as defined by the IWCLL criteria

• Must have measurable disease meeting one of the following criteria:

• Absolute lymphocyte count > 5,000/μL

• Measurable lymphadenopathy or organomegaly

• No tumor lysis syndrome (TLS) by Cairo-Bishop definition

• Patients with correction of electrolyte abnormalities allowed

• ECOG performance status 0-2

• ANC ≥ 1,500/mm³

• Platelet count ≥ 75,000/mm³

• Creatinine clearance ≥ 30 mL/min

• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST and ALT ≤ 3 times ULN (≤ 5 times ULN if hepatic metastases are present)

• Uric acid normal

• Patients with elevated uric acid allowed provided it is corrected with appropriate pharmacologic measures

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must commit to continued abstinence from heterosexual intercourse or use 2 acceptable methods of contraception (1 highly effective method and 1 additional effective method) ≥ 28 days prior to, during, and for ≥ 28 days after discontinuing lenalidomide

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

• No serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form

• No condition, including the presence of laboratory abnormalities, that would place the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

• No known hypersensitivity to thalidomide or lenalidomide

• No history of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs

• No history of any other cancer except non-melanoma skin cancer or carcinoma in-situ of the cervix or cancer for which the patient is in complete remission and off therapy for > 3 years

• No cardiac arrest within the past 6 months

• No known history of hepatitis B infection, positive hepatitis B surface antigen, or positive hepatitis C antibody

• No other concurrent anti-cancer agents or treatments

• More than 28 days since any prior experimental drug or therapy

• Aspirin (81 or 325 mg) or warfarin sodium daily as prophylactic anticoagulation required

• No prior lenalidomide