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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00582725
First received: December 19, 2007
Last updated: May 23, 2014
Last verified: May 2014

December 19, 2007
May 23, 2014
March 2002
December 2005   (final data collection date for primary outcome measure)
Response Rate to Therapy [ Time Frame: Dec 2005 approx ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00582725 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
R-CHOP + GM-CSF for Previously Untreated LCL in Elderly
Phase II Trial of Rituximab-CHOP (R-CHOP) Plus GM-CSF for Previously Untreated Diffuse Large Cell Lymphoma in the Elderly

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, Large B-Cell, Diffuse
Drug: R-CHOP+GM-CSF
addition of GM-CSF
Experimental: R-CHOP + GM-CSF
R-CHOP therapy (6-8 cycles) with GM-CSF
Intervention: Drug: R-CHOP+GM-CSF
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
November 2010
December 2005   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00582725
HO02401
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Brad Kahl, MD University of Wisconsin, Madison
University of Wisconsin, Madison
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP