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

Conditions

• AIDS Related Lymphoma
• AIDS-Associated Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Filgrastim — BIOLOGICAL
  Filgrastim after EPOCH-R from Day 6 for 10 days every cycle.
• Rituximab — BIOLOGICAL
  EPOCH-R every 3 weeks for up to 6 cycle
• EPOCH — DRUG
  EPOCH-R every 3 weeks for up to 6 cycle

Study Details

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.

Key Dates

Start date

Jan 8, 1997

Status verified

Jan 2022

Primary completion

May 5, 2005

Completion

May 5, 2005

Study Design

Enrollment

39 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 1
  EPOCH-R every 3 weeks for up to 6 cycle

Primary Outcome Measure

Determination of safety profile and response rates [ Time Frame: End of Study ]

Locations (1)

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