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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00582725
First Posted: December 28, 2007
Last Update Posted: May 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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 Drug: R-CHOP+GM-CSF Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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
Drug: R-CHOP+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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582725


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

Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582725     History of Changes
Other Study ID Numbers: HO02401
First Submitted: December 19, 2007
First Posted: December 28, 2007
Last Update Posted: May 26, 2014
Last Verified: May 2014

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin