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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006436
The ClinicalTrials.gov registry entry for NCT00006436 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Rituximab is the first listed.
NCT00006436 reports 0 study locations.
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.
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