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

Primary Purpose

Lymphoma, Large B-Cell, Diffuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
R-CHOP+GM-CSF
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse focused on measuring DLBCL, Elderly, previously untreated DLBCL in the elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R-CHOP + GM-CSF

Arm Description

R-CHOP therapy (6-8 cycles) with GM-CSF

Outcomes

Primary Outcome Measures

Response Rate to Therapy

Secondary Outcome Measures

Full Information

First Posted
December 19, 2007
Last Updated
December 12, 2019
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT00582725
Brief Title
R-CHOP + GM-CSF for Previously Untreated LCL in Elderly
Official Title
Phase II Trial of Rituximab-CHOP (R-CHOP) Plus GM-CSF for Previously Untreated Diffuse Large Cell Lymphoma in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse
Keywords
DLBCL, Elderly, previously untreated DLBCL in the elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R-CHOP + GM-CSF
Arm Type
Experimental
Arm Description
R-CHOP therapy (6-8 cycles) with GM-CSF
Intervention Type
Drug
Intervention Name(s)
R-CHOP+GM-CSF
Intervention Description
addition of GM-CSF
Primary Outcome Measure Information:
Title
Response Rate to Therapy
Time Frame
Dec 2005 approx

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad Kahl, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15779863
Citation
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.
Results Reference
result

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

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