NCT01649791

Lenalidomide as Chemoprevention in Treating Patients With High-Risk, Early-Stage B-Cell Chronic Lymphocytic Leukemia

A Pilot Study of Lenalidomide as a Chemopreventive Agent for Patients With High-Risk, Early Stage B-Chronic Lymphocytic Leukemia (CLL)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies lenalidomide as chemoprevention in treating patients with high-risk, early stage B-cell chronic lymphocytic leukemia (B-CLL). Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lenalidomide may slow disease progression in patients with early stage B-cell chronic lymphocytic leukemia

Detailed description

PRIMARY OBJECTIVES: I. To determine time to progression in patients with high risk CLL. SECONDARY OBJECTIVES: I. Overall response rate including (complete remission \[CR\]+partial remission \[PR\]) of lenalidomide. II. To determine the incidence of immune mediated flare reaction. III. To characterize the toxicity profile of single agent lenalidomide in previously untreated B-CLL. IV. To correlate expression of B-CLL co-stimulatory ligands and clinical efficacy of lenalidomide in this patient population. V. To conduct correlative studies. OUTLINE: Patients receive lenalidomide orally (PO) once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3 months for 5 years.

Conditions

• B-cell Chronic Lymphocytic Leukemia
• Chronic Lymphocytic Leukemia
• Stage 0 Chronic Lymphocytic Leukemia
• Stage I Chronic Lymphocytic Leukemia
• Stage II Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	lenalidomide	Given orally
OTHER	laboratory biomarker analysis	Correlative study
PROCEDURE	lymph node biopsy	Correlative study
PROCEDURE	bone marrow aspiration	Correlative study
OTHER	pharmacological study	Correlative study
OTHER	flow cytometry	Correlative study

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-05-01
• Completion: 2014-10-01
• First posted: 2012-07-25
• Last updated: 2016-06-30
• Results posted: 2014-02-27

Locations

1 site across 1 country: United States