Phase II Trial of Rituximab-CHOP (R-CHOP) Plus GM-CSF for Previously Untreated Diffuse Large Cell Lymphoma in the Elderly

University of Wisconsin, Madison1 site in 1 country38 target enrollmentMarch 2002

ConditionsLymphoma, Large B-Cell, Diffuse

InterventionsR-CHOP+GM-CSF

DrugsR-CHOP+GM-CSF

Overview

Phase: Phase 2
Intervention: R-CHOP+GM-CSF
Conditions: Lymphoma, Large B-Cell, Diffuse
Sponsor: University of Wisconsin, Madison
Enrollment: 38
Locations: 1
Primary Endpoint: Response Rate to Therapy
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.

Detailed Description

The objective of this study is to estimate complete response rates for patients treated with this regimen, to assess overall response rates, event-free survival and overall survival; and to assess toxicities associated with R-CHOP + GM-CSF. Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.

Registry

clinicaltrials.gov

Start Date

March 2002

End Date

November 2010

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Wisconsin, Madison

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed, CD20+ B cell diffuse large cell lymphoma, with measurable or evaluable disease
•Having no prior chemotherapy, immunotherapy or radiotherapy except for one cycle of CHOP or R-CHOP.