Evaluation of the Immune Restoration Potential Of Lenalidomide — Revlimid  

Chronic Lymphocytic Leukemia (CLL) Clinical Trial

Official title: A Phase 2 Clinical Trial To Evaluate The Immune Restoration Potential Of Lenalidomide For Patients With CLL-Associated Immunodeficiency

Status Withdrawn

Clinical Trial Summary

This is phase 2 study of the immunomodulatory drug, lenalidomide, to evaluate potential beneficial effects on the immune system of patients with chronic lymphocytic leukemia (CLL) and CLL-associated immunodeficiency. 17 patients will be enrolled with CLL, small lymphocytic lymphoma (SLL), or monoclonal B-cell lymphocytosis (MBL), and measurable immune compromise, but not an iwCLL indication for CLL therapy (ie non-progressive disease).

Clinical Trial Description

This is phase 2 study of the immunomodulatory drug, lenalidomide, to evaluate potential beneficial effects on the immune system of patients with chronic lymphocytic leukemia (CLL) and CLL-associated immunodeficiency. 17 patients will be enrolled with CLL, small lymphocytic lymphoma (SLL), or monoclonal B-cell lymphocytosis (MBL), and measurable immune compromise, but not an iwCLL indication for CLL therapy (ie non-progressive disease). Lenalidomide will be administered orally for 21 days of each 28 day cycle, starting at a 2.5mg dose, with dose escalation each cycle to a maximum of 25mg in the absence of any grade 2 or higher hematologic or non-hematologic adverse events. Treatment duration to primary endpoint assessment is 6 cycles, though patients will not be restricted from continuing lenalidomide off-study, if clinically indicated ;

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia (CLL)
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

• NCT number: NCT02371577
• Study type: Interventional
• Source: University of California, San Diego
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 1, 2017
• Completion date: December 2020