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

Completed · Phase 2

Conditions studied: Lymphoma, AIDS-related, Lymphoma, Large B-Cell, Diffuse

In brief

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.

Key facts

Study ID

NCT00006436

Run by

National Cancer Institute (NCI)

People needed

68

Starts

2001-01-29

Expected to finish

2024-01-18

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Previous rituximab
• Pregnancy or nursing.
• Doxorubicin, etoposide, vincristine and cyclophosphamide are teratogenic and may be excreted in milk.
• Current clinical heart failure or symptomatic ischemic heart disease.
• Serious underlying medical condition or infection other than HIV that would contraindicate subcutaneous (SC)-rituximab, etoposide phosphate, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (hydroxydaunorubicin (EPOCH-R).
• Examples include, but are not limited to:
• Severe Acquired immunodeficiency syndrome (AIDS)-related wasting
• Sever intractable diarrhea
• Active inadequately treated opportunistic infection of the central nervous system (CNS)
• Primary CNS lymphoma
• Primary CNS lymphoma

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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