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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00006436
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — BIOLOGICAL
    2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
  • Filgrastim — BIOLOGICAL
    Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
  • EPOCH — DRUG
    combination chemotheray: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles

Study Details

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 Dates

Start date
Jan 29, 2001
Status verified
Dec 2025
Primary completion
Nov 30, 2020
Completion
Jan 18, 2024

Study Design

Enrollment
68 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1-Combination Chemo and Biological Therapy
    Combination chemo and biological therapy

Primary Outcome Measure

Median Progression Free Survival (PFS) [ Time Frame: The participants were followed for a median of 15.4 years. ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By research site
National Institutes of Health Clinical Center, 9000 Rockville Pike· Bethesda, MD

Related Studies