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

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Lymphoma, Large B-Cell, Diffuse

Treatments: Drug: R-CHOP+GM-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT00582725

HO02401

NCI-2011-00578 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

R-CHOP + GM-CSF

Experimental group

Description:

R-CHOP therapy (6-8 cycles) with GM-CSF

Treatment:

Drug: R-CHOP+GM-CSF