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

This study is ongoing, but not recruiting participants.

First Received: December 19, 2007 Last Updated: March 30, 2009 History of Changes

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00582725

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 II

MedlinePlus related topics: Lymphoma

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

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

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

Primary Outcome Measures:

Response Rate to Therapy [ Time Frame: Dec 2005 approx ] [ Designated as safety issue: No ]

Enrollment:	38
Study Start Date:	March 2002
Estimated Study Completion Date:	December 2009
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Intervention Details:

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

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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.

Responsible Party:	University of Wisconsin ( Brad Kahl MD )
Study ID Numbers:	HO02401
Study First Received:	December 19, 2007
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00582725 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

DLBCL, Elderly
previously untreated DLBCL in the elderly

Study placed in the following topic categories:

Lymphoma, B-Cell
Lymphatic Diseases
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
B-cell Lymphomas

Rituximab
Lymphoma, Large-cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Lymphoma, B-Cell
Lymphatic Diseases
Neoplasms
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders

Neoplasms by Histologic Type
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009