Lenalidomide as Chemoprevention in Treating Patients With High-Risk, Early-Stage B-Cell Chronic Lymphocytic Leukemia
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|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: laboratory biomarker analysis
Procedure: lymph node biopsy
Other Name: Biopsy of Lymph Node
Procedure: bone marrow aspiration
Other: pharmacological study
Other Name: pharmacological studies
Other: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|