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Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

2014-08-27 03:54:39 | BioPortfolio

Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which rituximab regimen is more effective in treating indolent non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and comparing them to see how well they work in treating patients with low tumor burden indolent stage III non-Hodgkin's lymphoma or stage IV non-Hodgkin's lymphoma.

Description

OBJECTIVES:

Primary

- Compare the time to rituximab failure in patients with low tumor burden indolent non-Hodgkin's lymphoma treated with rituximab scheduled vs rituximab retreatment.

Secondary

- Compare the time to first cytotoxic therapy in patients treated with these regimens.

- Determine the rationale for beginning cytotoxic therapy, defined as chemotherapy, radiotherapy, or radioimmunotherapy, in patients treated with these regimens.

- Compare the toxic effects associated with these regimens in these patients.

- Correlate response and duration of response in these patients with rituximab pharmacokinetics.

- Compare the health-related quality of life, distress, psychological functioning, physical well-being, and functional well-being of patients treated with these regimens.

- Compare the impact of differential treatment response (delayed time to rituximab failure and/or time to first cytotoxic therapy) on quality of life, distress, and psychological functioning in patients treated with these regimens.

- Determine, prospectively, the physical and functional well-being of patients during treatment with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histologic subtype (follicular vs other), age (under 60 vs 60 and over), and the time from diagnosis (less than 1 year vs at least 1 year).

- Induction rituximab: Patients receive rituximab IV once a week for 4 weeks. Patients are re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab are randomized to 1 of 2 treatment arms.

- Arm I (retreatment rituximab): Patients receive rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.

- Arm II (scheduled rituximab): Patients receive a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.

Quality of life is assessed after induction rituximab treatment and at 26, 39, 65, 117, 169, and 221 weeks after randomization.

Patients are followed at least annually for 15 years from study entry.

PROJECTED ACCRUAL: A total of 389 patients will be accrued for this study within 45 months.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment

Conditions

Lymphoma

Intervention

rituximab

Location

Mayo Clinic Scottsdale
Scottsdale
Arizona
United States
85259-5499

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:39-0400

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Medical and Biotech [MESH] Definitions

A murine-derived monoclonal antibody and ANTINEOPLASTIC AGENT that binds specifically to the CD20 ANTIGEN and is used in the treatment of LEUKEMIA; LYMPHOMA and RHEUMATOID ARTHRITIS.

A leukemia/lymphoma found predominately in children and young adults and characterized LYMPHADENOPATHY and THYMUS GLAND involvement. It most frequently presents as a lymphoma, but a leukemic progression in the bone marrow is common.

B-cell lymphoid tumors that occur in association with AIDS. Patients often present with an advanced stage of disease and highly malignant subtypes including BURKITT LYMPHOMA; IMMUNOBLASTIC LARGE-CELL LYMPHOMA; PRIMARY EFFUSION LYMPHOMA; and DIFFUSE, LARGE B-CELL, LYMPHOMA. The tumors are often disseminated in unusual extranodal sites and chromosomal abnormalities are frequently present. It is likely that polyclonal B-cell lymphoproliferation in AIDS is a complex result of EBV infection, HIV antigenic stimulation, and T-cell-dependent HIV activation.

A form of undifferentiated malignant LYMPHOMA usually found in central Africa, but also reported in other parts of the world. It is commonly manifested as a large osteolytic lesion in the jaw or as an abdominal mass. B-cell antigens are expressed on the immature cells that make up the tumor in virtually all cases of Burkitt lymphoma. The Epstein-Barr virus (HERPESVIRUS 4, HUMAN) has been isolated from Burkitt lymphoma cases in Africa and it is implicated as the causative agent in these cases; however, most non-African cases are EBV-negative.

Two or more distinct types of malignant lymphoid tumors occurring within a single organ or tissue at the same time. It may contain different types of non-Hodgkin lymphoma cells or both Hodgkin and non-Hodgkin lymphoma cells.

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