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

NCT00193479 ↗

Phase 2 Completed 51 enrolled SCRI Development Innovations, LLC Amgen · collab Genentech, Inc. · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2003-04
Primary completion: 2008-07
Completion: 2010-02

Publications

Results Hainsworth JD, Flinn IW, Spigel DR, Clark BL, Griner PL, Vazquez ER, Doss HH, Shipley D, Franco LA, Burris HA 3rd, Greco FA; Sarah Cannon Oncology Research Consortium. Brief-duration rituximab/chemotherapy followed by maintenance rituximab in patients with diffuse large B-cell lymphoma who are poor candidates for R-CHOP chemotherapy: a phase II trial of the Sarah Cannon Oncology Research Consortium. Clin Lymphoma Myeloma Leuk. 2010 Feb;10(1):44-50. doi: 10.3816/CLML.2010.n.004.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclophosphamide	Other / unclassified	500 mg/m2	Intravenous
Subject	Mitoxantrone	Small molecule	10 mg/m2	Intravenous
Subject	Prednisone	Other / unclassified	80 mg	Oral
Subject	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Subject	Vincristine	Small molecule	1 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications