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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2010-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Non-Hodgkins Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cyclophosphamide/Vincristine/Rituximab +/- Mitoxantrone

All patients receive three courses of combination chemotherapy/rituximab followed by pegfilgrastim, administered at 21-day intervals. Treatment administered is as follows: cyclophosphamide 500mg/m2 IV day 1; mitoxantrone 10mg/m2 IV day 1; vincristine 1.0mg/m2 (maximum 2mg) IV day 1; prednisone 80mg PO days 1 - 5; rituximab 375mg/m2 IV day 1.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide

Mitoxantrone

Intervention Type DRUG

Mitoxantrone

Vincristine

Intervention Type DRUG

Vincristine

Prednisone

Intervention Type DRUG

Prednisone

Rituximab

Intervention Type DRUG

Rituximab

Interventions

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Cyclophosphamide

Intervention Type DRUG

Mitoxantrone

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Rituximab

Intervention Type DRUG

Other Intervention Names

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Cytoxan Novantrone Oncovin Rituxan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No