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

Lymphoma, Large B-Cell, Diffuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582725
• Other study ID #: HO02401
• Secondary ID: NCI-2011-00578
• Status: Completed
• Phase: Phase 2
• Start date: March 2002
• Est. completion date: November 2010

Study information

• Verified date: May 2014
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2010
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• R-CHOP+GM-CSF
addition of GM-CSF

Locations

Country	Name	City	State
United States	University Of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Cance — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate to Therapy		Dec 2005 approx