Lenalidomide as Chemoprevention in Treating Patients With High-Risk, Early-Stage B-Cell Chronic Lymphocytic Leukemia
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
B-cell Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
Stage 0 Chronic Lymphocytic Leukemia
Stage I Chronic Lymphocytic Leukemia
Stage II Chronic Lymphocytic Leukemia
Other: laboratory biomarker analysis
Procedure: lymph node biopsy
Procedure: bone marrow aspiration
Other: pharmacological study
Other: flow cytometry
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Lenalidomide as a Chemopreventive Agent for Patients With High-Risk, Early Stage B-Chronic Lymphocytic Leukemia (CLL)|
- Median Progression-free Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Overall Response Rate (CR+PR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Incidence of Immune Mediated Flare Reaction [ Time Frame: 24 months ] [ Designated as safety issue: No ]Number of participants with Tumour flare.
- Expression of B-CLL Co-stimulatory Ligands, Mic-A, and Mic-B Assessed by Flow Cytometry [ Time Frame: 8 days ] [ Designated as safety issue: No ]PI left the institute and the data was not collected.
|Study Start Date:||January 2010|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment (lenalidomide as chemoprevention)
Patients receive lenalidomide 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.
Other Names:Other: laboratory biomarker analysis
Correlative studyProcedure: lymph node biopsy
Other Name: Biopsy of Lymph NodeProcedure: bone marrow aspiration
Correlative studyOther: pharmacological study
Other Name: pharmacological studiesOther: flow cytometry
I. To determine time to progression in patients with high risk CLL.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649791
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Myron Czuczman||Roswell Park Cancer Institute|