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

StatusCompleted
PhasePhase 2
Started

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Record History

The 50 most recent of 178 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Dec 15, 2025, no change to tracked fieldsv177-v178
  2. Minor Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Mar 30, 2027 to Jan 18, 2024
    v176
  3. 2 versions Re-verified since Jul 25, 2023, no change to tracked fieldsv174-v175
  4. Minor Secondary endpoints revised (13)v173
  5. Notable Results first posted: Jun 28, 2022v172 Show 5 more changesShow less
    • Primary endpoints: 1 to 2
    • Interventions: EPOCH (Drug), Rituximab (Biological), filgrastim (Biological) to EPOCH (Drug), Filgrastim (Biological), Rituximab (Biological)
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: 2 to 13
    • Study description expanded, about 31 words
Show 43 earlier versionsHide 43 earlier versions
  1. 2 versions Re-verified since Mar 9, 2022, no change to tracked fieldsv170-v171
  2. Minor Primary completion date changed from estimate of Mar 31, 2023 to Nov 30, 2020v169
  3. 2 versions Re-verified since Feb 15, 2022, no change to tracked fieldsv167-v168
  4. Minor Secondary endpoints revised (2)v166
  5. 18 versions Re-verified since May 15, 2021, no change to tracked fieldsv148-v165
  6. Minor Eligibility criteria revisedv147
  7. Re-verified, no change to tracked fieldsv146
  8. Minor Eligibility criteria revised
    • Study description revised
    v145
  9. Re-verified, no change to tracked fieldsv144
  10. Notable Primary completion date: Mar 31, 2022 to Mar 31, 2023v143
  11. 5 versions Re-verified since Feb 6, 2021, no change to tracked fieldsv138-v142
  12. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 80 to confirmed 68
    • Site details revised
    v137
  13. 8 versions Re-verified since Oct 7, 2020, no change to tracked fieldsv129-v136
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00006436
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)
Lymphoma, AIDS-related, Lymphoma, Large B-Cell, Diffuse
Related terms Acquired Immunodeficiency Syndrome, Lymphoma, AIDS-Related, Lymphoma, Large B-Cell, Diffuse, Neoplasms
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov