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OpenTrials
Completed

NCT Number: NCT00582725

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

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

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Key information

Conditions

Lymphoma, Large B-Cell, Diffuse Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

R-CHOP+GM-CSF

Drug

addition of GM-CSF

Primary outcomes

  1. Response Rate to Therapy

    Time frame: Dec 2005 approx

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2005
Study completion
2010
First posted
Dec 28, 2007
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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