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

NCT ID: NCT00582725

Last Updated: 2019-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2010-11-30

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.

Conditions

Lymphoma, Large B-Cell, Diffuse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R-CHOP + GM-CSF

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

Group Type: EXPERIMENTAL

R-CHOP+GM-CSF

Intervention Type: DRUG

addition of GM-CSF

Interventions

R-CHOP+GM-CSF

addition of GM-CSF

Intervention Type: DRUG

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.

Exclusion Criteria

• Pregnant
• Hepatitis B Surface Antigen positive
• Have known CNS disease or HIV infection
• Have NY Classification III or IV disease.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brad Kahl, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University Of Wisconsin

Madison, Wisconsin, United States

Countries

United States

References

Kahl BS, Bailey HH, Smith EP, Turman N, Smith J, Werndli J, Williams EC, Longo WL, Kim KM, McGovern J, Jumonville A. Phase II study of weekly low-dose paclitaxel for relapsed and refractory non-Hodgkin's lymphoma: a Wisconsin Oncology Network Study. Cancer Invest. 2005;23(1):13-8.

Reference Type: RESULT

PMID: 15779863 (View on PubMed)

Other Identifiers

NCI-2011-00578

Identifier Type: REGISTRY

Identifier Source: secondary_id

HO02401

Identifier Type: -

Identifier Source: org_study_id