Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic Leukemia

Withdrawn before enrolling · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT01271283

Run by

National Cancer Institute (NCI)

People needed

0

Starts

2010-12-01

Expected to finish

2011-08-01

Last updated by the study team

2015-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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