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Rituximab and Alemtuzumab in Treating Older Patients With Progressive Chronic Lymphocytic Leukemia

2014-08-27 03:17:57 | BioPortfolio

Summary

RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Giving rituximab together with alemtuzumab may kill more cancer cells.

PURPOSE: This randomized phase II trial is studying two different doses of rituximab to compare how well they work when given together with alemtuzumab in treating older patients with progressive chronic lymphocytic leukemia.

Description

OBJECTIVES:

Primary

- To compare the rate of complete and overall response in elderly patients with progressive chronic lymphocytic leukemia (CLL) treated with one of two doses of rituximab combined with alemtuzumab to determine if the use of modified-dose rituximab significantly affects outcome.

Secondary

- To monitor and assess toxicity of these regimens.

- To determine the overall and progression-free survival, time to clinical response, time to next treatment, and duration of response in patients treated with these regimens

- To assess the correlation between risk stratification prognostic markers (i.e., CD38, ZAP-70, FISH, and IgVH mutation) and clinical outcome.

- To assess response to these regimens using both the NCI-WG 96 criteria and an expanded definition of response for patients in complete remission, including immunohistochemical examination of the bone marrow and sensitive flow cytometry (4-6 color) of blood for minimal residual disease and CT scans for residual adenopathy.

- To determine the mechanism of action of rituximab and alemtuzumab and to detail the in vivo effect of this regimen on critical aspects of the immune system in select patients with CLL.

OUTLINE: This is a multicenter study. Patients are stratified according to FISH risk (low [13q14-] vs intermediate [12+, no abnormality, all other abnormalities] vs high [17p13-,11q22-]). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab IV on days 8, 15, 22, and 29 in course 1. In courses 2 and 3, patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive alemtuzumab as in arm I. Patients also receive low-dose rituximab IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in course 1 and on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in courses 2 and 3. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Blood and bone marrow samples are collected periodically for cytogenetic and biomarker analysis.

After completion of study therapy, patients are followed up periodically for 5 years.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Conditions

Leukemia

Intervention

alemtuzumab, rituximab

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:57-0400

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