Lenalidomide as Chemoprevention in Treating Patients With High-Risk, Early-Stage B-Cell Chronic Lymphocytic Leukemia
|ClinicalTrials.gov Identifier: NCT01649791|
Recruitment Status : Terminated
First Posted : July 25, 2012
Results First Posted : February 27, 2014
Last Update Posted : June 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|B-cell Chronic Lymphocytic Leukemia Chronic Lymphocytic Leukemia Stage 0 Chronic Lymphocytic Leukemia Stage I Chronic Lymphocytic Leukemia Stage II Chronic Lymphocytic Leukemia||Drug: lenalidomide Other: laboratory biomarker analysis Procedure: lymph node biopsy Procedure: bone marrow aspiration Other: pharmacological study Other: flow cytometry||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Lenalidomide as a Chemopreventive Agent for Patients With High-Risk, Early Stage B-Chronic Lymphocytic Leukemia (CLL)|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||October 2014|
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
- Median Progression-free Survival [ Time Frame: 24 months ]
- Overall Response Rate (CR+PR) [ Time Frame: 24 months ]
- Incidence of Immune Mediated Flare Reaction [ Time Frame: 24 months ]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 ]PI left the institute and the data was not collected.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649791
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Myron Czuczman||Roswell Park Cancer Institute|