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NCT00006436 · ClinicalTrials.gov registry record · Phase 2
EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
NCT00006436: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00006436 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006436, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
Study 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.
Primary Outcome
PFS is the time interval from study entry to documented evidence of disease progression or death due to any cause. Progression is defined according to the Cheson response criteria. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s). Confidence intervals were made, and a Kaplan-Meier curve of progression free surviv
Interventions
- BIOLOGICAL Rituximab
- BIOLOGICAL Filgrastim
- DRUG EPOCH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2001-01-29 |
| Est. Completion | 2024-01-18 |
| Phase | Phase 2 |
What the finished NCT00006436 record still lists
NCT00006436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 3 interventions - of which Rituximab is the first listed.
NCT00006436 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00006436 about?
NCT00006436 is a clinical study titled "EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection". 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 infection...
What is the current status of trial NCT00006436?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2001-01-29. Estimated completion is 2024-01-18.
What interventions are being tested in trial NCT00006436?
The interventions under investigation include: Rituximab (BIOLOGICAL), Filgrastim (BIOLOGICAL), EPOCH (DRUG).
Who is sponsoring clinical trial NCT00006436?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00006436's enrollment target sits among peer trials
68 967th of 2000 higher than 1,027 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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