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

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00582725
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arm: 1
• Duration (Months): 104
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Large B-Cell, Diffuse	Drug: R-CHOP+GM-CSF	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• 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
• Study Start Date: Mar 1, 2002
• Actual Primary Completion Date: Dec 1, 2005
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: R-CHOP + GM-CSF R-CHOP therapy (6-8 cycles) with GM-CSF	Drug: R-CHOP+GM-CSF; addition of GM-CSF

Outcome Measures

Primary Outcome Measures

1. Response Rate to Therapy [Dec 2005 approx]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00582725
• Other Study ID Numbers: HO02401; NCI-2011-00578
• First Posted: Dec 28, 2007
• Last Update Posted: Dec 13, 2019
• Last Verified: May 1, 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

Study Results

No Results Posted as of Dec 13, 2019