NCT00193479

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Non-Hodgkins Lymphoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cyclophosphamide
DRUG	Mitoxantrone	Mitoxantrone
DRUG	Vincristine	Vincristine
DRUG	Prednisone	Prednisone
DRUG	Rituximab	Rituximab

Timeline

• Start date: 2003-04-01
• Primary completion: 2008-07-01
• Completion: 2010-02-01
• First posted: 2005-09-19
• Last updated: 2022-03-03
• Results posted: 2014-02-21

Locations

2 sites across 1 country: United States