A Phase II Clinical Trial of Sapacitabine, Cyclophosphamide, and Rituximab (SCR) for Relapsed Patients with Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) and Deletion 11q22-23 by FISH
William G. Wierda
The goal of this clinical research study is to learn if sapacitabine given in combination with 2 standard drugs (cyclophosphamide and rituximab) can help to control CLL and SLL. The safety of this drug combination will also be studied.
Treatment Location: N/A
Primary objective: Evaluate efficacy (2008 International Workshop on Chronic Lymphocytic Leukemia [IWCLL] overall response rate) of the SCR regimen in previously treated patients with CLL who have deletion 11q22-23 by FISH. Secondary objectives: Evaluate the association between IWCLL response (CR, PR, and OR) to SCR and ATM function in previously treated patients with CLL who have deletion 11q22-23 by FISH. Evaluate toxicities, safety and tolerability of the SCR regimen in previously treated patients with CLL who have deletion 11q22-23 by FISH. Evaluate the number of courses of SCR to best response and overall number of courses SCR administered to each patient. Evaluate time-to-treatment failure (TTF), time-to-progression (TTP) for responders, and overall survival for previously treated patients with CLL who have deletion 11q22-23 by FISH treated with SCR. Also, evaluate the association between these time-to-event endpoints and ATM function. Correlate pretreatment prognostic factors, including ZAP-70 expression, CD38 expression, beta-2 microglobulin, IGHV mutation status, response and time-to-event outcomes. Evaluate pharmacodynamic endpoints including 1) quantitate the proportion of proliferating cells (proliferating fraction) in blood and/or bone marrow by flow cytometry before and during treatment and 2) quantitate DNA double-strand breaks in blood and bone marrow lymphocytes by staining for Rad51 foci and evaluating cells by confocal microscopy, and 3) measure changes in apoptosis during therapy.
IRB Review and Approval Date: 07/20/2011
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
William G. Wierda
For general questions about clinical trials: