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Ofatumumab, Pentostatin, and Cyclophosphamide in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

2014-08-27 03:17:37 | BioPortfolio

Summary

RATIONALE: Monoclonal antibodies, such as ofatumumab, 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. Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving ofatumumab together with pentostatin and cyclophosphamide may be a better way to block cancer growth.

PURPOSE: This phase II trial is studying how well giving ofatumumab together with pentostatin and cyclophosphamide works in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Description

PRIMARY OBJECTIVES:

I. To assess the rate of complete and overall response using pentostatin, cyclophosphamide, and ofatumumab in patients with previously untreated CLL or SLL requiring therapy and to determine the proportion of patients who achieve a minimal residual disease (MRD) negative state as assessed by flow cytometry.

SECONDARY OBJECTIVES:

I. To monitor and assess toxicity of pentostatin, cyclophosphamide, and ofatumumab in patients with previously untreated CLL or SLL.

II. To determine the progression-free survival in CLL patients treated with pentostatin, cyclophosphamide, and ofatumumab.

III. To assess the complete and overall response as well as progression-free survival of CLL patients treated with pentostatin, cyclophosphamide, and ofatumumab as compared to a historic control of patients treated with pentostatin, cyclophosphamide, and rituximab in an exploratory manner.

IV. To determine if molecular prognostic parameters (ZAP-70, CD38, cytogenetic abnormalities identified by FISH, IgVH mutation status, etc) relate to response to PCO therapy.

V. Assess the mechanisms of ofatumumab induced cell death and explore methods to enhance ofatumumab cytotoxicity.

OUTLINE: Patients receive ofatumumab IV on days 1-2 of course 1 and on day 1 of courses 2-6. Patients also receive pentostatin IV over 30 minutes on day 1, cyclophosphamide IV over 30 minutes on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hematopoietic/Lymphoid Cancer

Intervention

pentostatin, cyclophosphamide, ofatumumab, laboratory biomarker analysis, flow cytometry, protein expression analysis

Location

Mayo Clinic Scottsdale-Phoenix
Scottsdale
Arizona
United States
85259

Status

Recruiting

Source

Mayo Clinic

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:37-0400

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A technique encompassing morphometry, densitometry, neural networks, and expert systems that has numerous clinical and research applications and is particularly useful in anatomic pathology for the study of malignant lesions. The most common current application of image cytometry is for DNA analysis, followed by quantitation of immunohistochemical staining.

The analysis of a chemical substance by inserting a sample into a carrier stream of reagent using a sample injection valve that propels the sample downstream where mixing occurs in a coiled tube, then passes into a flow-through detector and a recorder or other data handling device.

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.

Process of classifying cells of the immune system based on structural and functional differences. The process is commonly used to analyze and sort T-lymphocytes into subsets based on CD antigens by the technique of flow cytometry.

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