R-CHOP + GM-CSF for Previously Untreated LCL in Elderly

University of Wisconsin, Madison38 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

R-CHOP+GM-CSFDRUG

addition of GM-CSF

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: * Pregnant * Hepatitis B Surface Antigen positive * Have known CNS disease or HIV infection * Have NY Classification III or IV disease.

Locations (1)

University Of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Response Rate to Therapy

Time frame: Dec 2005 approx

Data from ClinicalTrials.gov

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