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

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: December 19, 2007
Last updated: May 23, 2014
Last verified: May 2014
Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.

Condition Intervention Phase
Lymphoma, Large B-Cell, Diffuse
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Rituximab-CHOP (R-CHOP) Plus GM-CSF for Previously Untreated Diffuse Large Cell Lymphoma in the Elderly

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Response Rate to Therapy [ Time Frame: Dec 2005 approx ]

Enrollment: 38
Study Start Date: March 2002
Study Completion Date: November 2010
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: R-CHOP + GM-CSF
R-CHOP therapy (6-8 cycles) with GM-CSF
addition of 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.

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00582725

United States, Wisconsin
University Of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Brad Kahl, MD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison Identifier: NCT00582725     History of Changes
Other Study ID Numbers: HO02401
Study First Received: December 19, 2007
Last Updated: May 23, 2014

Keywords provided by University of Wisconsin, Madison:
DLBCL, Elderly
previously untreated DLBCL in the elderly

Additional relevant MeSH terms:
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin processed this record on May 25, 2017