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

Information source: SCRI Development Innovations, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Hodgkins Lymphoma

Intervention: Cyclophosphamide (Drug); Mitoxantrone (Drug); Vincristine (Drug); Prednisone (Drug); Rituximab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: SCRI Development Innovations, LLC

Official(s) and/or principal investigator(s):
John D. Hainsworth, MD, Principal Investigator, Affiliation: SCRI Development Innovations, LLC

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.

Clinical Details

Official title: A Phase II Trial of Brief Duration Combination Chemotherapy and Rituximab With Prophylactic Pegfilgrastim, Followed by Maintenance Rituximab, in Elderly/Poor Performance Status Patients With Large B-Cell Non-Hodgkin's Lymphoma

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

Primary outcome: Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Florida Cancer Specialists, Fort Myers, Florida 33901, United States

Tennessee Oncology, Nashville, Tennessee 37203, United States

Additional Information

Published article in Clinical Lymphoma, Myeloma and Leukemia

Starting date: April 2003
Last updated: January 8, 2014

Page last updated: August 23, 2015

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