Non Hodgkin Lymphoma Clinical Trial

Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin’s Lymphoma

Summary

The purposes of this trial are to decrease toxicity and improve treatment effectiveness elderly patients. With a short course of chemotherapy with cyclophosphamide, mitoxantrone, vincristine, and prednisone with concurrent administration of rituximab it is likely to be as effective as longer programs, and will certainly be better tolerated by this patient group. The addition of maintenance therapy may result in substantial prolongation of remission duration.

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Full Description

Upon determination of eligibility, patients will receive:

Cyclophosphamide + Mitoxantrone + Vincristine + Prednisone + Rituximab

Patients that are not considered candidates for anthracycline therapy will not receive mitoxantrone. Patients with objective response (partial or complete response) or stable disease will receive Rituximab maintenance therapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

Histologically documented large B-cell, CD20-positive non-Hodgkin's lymphoma
No previous treatment
Clinical stage II, III, or IV by the Ann Arbor Staging Criteria
Age > 70 years
ECOG performance status 0, 1, or 2
Adequate bone marrow, liver and kidney function
Must give written informed consent prior to entering this trial

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

Age < 18 years
Central nervous system involvement with lymphoma
Coexistent active malignancies treated within five years
Active infection precluding the use of combination chemotherapy
HIV infection
Pregnant or lactating

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

51

Study ID:

NCT00193479

Recruitment Status:

Completed

Sponsor:

SCRI Development Innovations, LLC

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There are 2 Locations for this study

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Florida Cancer Specialists
Fort Myers Florida, 33901, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

51

Study ID:

NCT00193479

Recruitment Status:

Completed

Sponsor:


SCRI Development Innovations, LLC

How clear is this clinincal trial information?

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