MedTrace Logo

EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection

NCT00006436 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-12-30

Study results available
· View outcomes & findings →

Summary

Background:

* Human immunodeficiency virus (HIV)-infected patients have a weakened immune system, and chemotherapy, which is used to treat lymphoma, probably causes further damage to the immune system.
* Limiting the amount of immune damage due to chemotherapy might decrease the number of infections and the risk of developing cancer in the future in HIV-infected patients with non-Hodgkin's lymphoma.

Objectives:

* To determine whether reducing the total amount of chemotherapy using a specific combination of drugs called EPOCH-R (etoposide, doxorubicin, vincristine, cyclophosphamide and rituximab) will rid the body of lymphoma quickly while decreasing the risk of infections and future cancers.
* To determine whether the lymphoma will remain undetectable for at least one year if treatment is stopped one cycle after the patient enters remission.

Eligibility:

-Patients with non-Hodgkin's lymphoma and HIV infection 4 years of age and older who have not been treated previously with rituximab or cytotoxic chemotherapy.

Design:

* Patients receive EPOCH-R in 3-week treatment cycles for at least three and no more than six cycles.
* The lymphoma is evaluated using computed tomography (CT) and positron emission tomography (PET) scans at the end of treatment cycles 2 and 3. A bone marrow biopsy is repeated after cycle 2 if a biopsy was initially positive on screening for participation in the study.
* Anti-HIV therapy is stopped before chemotherapy begins and is restarted when EPOCH-R treatment ends.
* Patients are monitored for treatment response with blood tests and imaging scans at baseline, when treatment ends, 2 months after treatment ends and then every 3 to 6 months for a total of 24 months following chemotherapy.

Conditions

  • Lymphoma, AIDS-related
  • Lymphoma, Large B-Cell, Diffuse

Interventions

BIOLOGICAL

Rituximab

2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5

BIOLOGICAL

Filgrastim

Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle

DRUG

EPOCH

combination chemotheray: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Max Gordon, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-29
Primary Completion
2020-11-30
Completion
2024-01-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006436 on ClinicalTrials.gov