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


Phase 2
60 Years
N/A
Not Enrolling
Both
Lymphoma, Large B-Cell, Diffuse

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate to Therapy

Outcome Time Frame:

Dec 2005 approx

Safety Issue:

No

Principal Investigator

Brad Kahl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

HO02401

NCT ID:

NCT00582725

Start Date:

March 2002

Completion Date:

November 2010

Related Keywords:

  • Lymphoma, Large B-Cell, Diffuse
  • DLBCL, Elderly
  • previously untreated DLBCL in the elderly
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse

Name

Location
University of Wisconsin Madison,, Wisconsin  53792-5666