EPOCH Chemotherapy +/- IL-12 for Previously Untreated and EPOCH Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma

Phase 2

Completed

• Conditions: AIDS Related Lymphoma; AIDS-Associated Lymphoma
• Interventions: Biological: Filgrastim; Biological: Rituximab; Drug: EPOCH

• Registration Number: NCT00001563
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

The prognosis of AIDS-related Non-Hodgkin's lymphoma is poor, especially in the relapsed setting. There is no standard treatment, and the few small studies that have been conducted have reported dismal outcomes. The purpose of this study is to pilot the use of EPOCH plus rituximab in previously treated AIDS-related lymphoma. Clinical endpoints of the study include toxicity and response. Progression-free and overall survival will be measured. Tumors will be evaluated for p53 mutations, p-16, bcl-2 expression, tumor proliferation, c-myc and EBV when possible.

Detailed Description

The prognosis of AIDS-related Non-Hodgkin's lymphoma is poor, especially in the relapsed setting. There is no standard treatment, and the few small studies that have been conducted have reported dismal outcomes. The purpose of this study is to pilot the use of EPOCH plus rituximab in previously treated AIDS-related lymphoma. Clinical endpoints of the study include toxicity and response. Progression-free and overall survival will be measured. Tumors will be evaluated for p53 mutations, p-16, bcl-2 expression, tumor proliferation, c-myc and EBV when possible.

Study Timeline

• Study Start: 1997-01-08
• Study First Submitted: 1999-11-03
• Study First Submitted QC: 1999-11-03
• Study First Posted: 1999-11-04
• Primary Completion: 2005-05-05
• Study Completion: 2005-05-05
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Filgrastim	EPOCH-R every 3 weeks for up to 6 cycle
1	Rituximab	EPOCH-R every 3 weeks for up to 6 cycle
1	EPOCH	EPOCH-R every 3 weeks for up to 6 cycle

Primary Outcome Measures

Name	Time	Method
Determination of safety profile and response rates	End of Study	number and types of adverse events {AEs), as well as the number of patients who respond to the therapy {CR, PR, SD)

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States