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Minor2 versionsRe-verified since Dec 15, 2025, no change to tracked fieldsv177-v178
MinorTrial status: Active, Not Recruiting to CompletedStudy completion date changed from estimate of Mar 30, 2027 to Jan 18, 2024v176Show 1 more changeShow less
Study completion date changed from estimate of Mar 30, 2027 to Jan 18, 2024
Minor2 versionsRe-verified since Jul 25, 2023, no change to tracked fieldsv174-v175
NotableResults first posted: Jun 28, 2022Primary endpoints: 1 to 2 · Interventions: EPOCH (Drug), Rituximab (Biological), filgrastim (Biological) to EPOCH (Drug), Filgrastim (Biological), Rituximab (Biological) · Eligibility criteria expanded, about 47 words · 2 morev172Show 5 more changesShow less
NotablePrimary completion date: Mar 31, 2022 to Mar 31, 2023v143
Minor5 versionsRe-verified since Feb 6, 2021, no change to tracked fieldsv138-v142
MinorTrial status: Recruiting to Active, Not RecruitingEnrollment target: estimated 80 to confirmed 68 · Site details revisedv137Show 2 more changesShow less
Enrollment target: estimated 80 to confirmed 68
Site details revised
Minor8 versionsRe-verified since Oct 7, 2020, no change to tracked fieldsv129-v136
Stopped: an ongoing trial was terminated, suspended or withdrawn.
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.