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

SCRI Development Innovations

Status and phase: Completed; Phase 2

Conditions: Non-Hodgkins Lymphoma

Treatments: Drug: Prednisone; Drug: Mitoxantrone; Drug: Rituximab; Drug: Vincristine; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00193479

SCRI LYM 28

Details and patient eligibility

About

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.

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Cyclophosphamide/Vincristine/Rituximab +/- Mitoxantrone

Experimental group

Description:

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.

Treatment:

Drug: Cyclophosphamide

Drug: Rituximab

Drug: Vincristine

Drug: Mitoxantrone

Drug: Prednisone