Spots Global Cancer Trial Database for Evaluation of the Immune Restoration Potential Of Lenalidomide

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Trial Identification

Brief Title: Evaluation of the Immune Restoration Potential Of Lenalidomide

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

Study ID: NCT02371577

Conditions

Chronic Lymphocytic Leukemia (CLL)

Interventions

Lenalidomide

Study Description

Brief 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).

Detailed 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