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NCT01092182 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Dose-Adjusted EPOCH-Rituximab in Adults With Untreated Burkitt Lymphoma and c-MYC+ Diffuse Large B-Cell Lymphoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 194
- Enrollment target
NCT01092182: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01092182 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 194 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01092182, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 194 participants
- Enrollment target
Study Summary
Background: * Burkitt lymphoma/leukemia (BL) is highly treatable, but most of the standard therapies require multiple doses of intensive chemotherapy that may require long hospital stays and frequently have severe side effects. In addition, BL is a fairly common type of cancer in patients who also have human immunodeficiency virus (HIV), but treatment outcomes are poor because standard treatments do not work very well in HIV-positive patients and the more intense treatment regimens are highly toxic. New approaches are needed that expand the ways to treat BL with the same efficiency but with reduced side effects. * Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) is a standard chemotherapy treatment that consists of the drugs etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab. It may be able to treat BL with similar effectiveness but with fewer side effects. Researchers are interested in confirming the results of previous studies that investigated the effectiveness of DA-EPOCH-R in treating BL. Objectives: \- To determine the safety and effectiveness of DA-EPOCH-R in treating Burkitt lymphoma. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with Burkitt lymphoma and have not had any prior chemotherapy treatments. Design: * Individuals will have a series of blood and other tests to determine their suitability for participating in the study. Eligible participants will be divided into high-risk and low-risk groups based on their disease prognosis and the possibility that the BL may or already has spread into the central nervous system. * Participants will receive intravenous infusion of the six chemotherapy drugs in DA-EPOCH-R in 21-day treatment cycles. The exact doses will be adjusted depending on participants white blood cell counts and other tests. * High-risk participants will receive six cycles of DA-EPOCH-R. To treat BL that may have entered the central
Interventions
- DRUG EPOCH-R
- DRUG EPOCH-RR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2010-03-25 |
| Est. Completion | 2023-02-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01092182
The ClinicalTrials.gov registry entry for NCT01092182 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 194 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 2 interventions - of which EPOCH-R is the first listed.
NCT01092182 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01092182 about?
NCT01092182 is a clinical study titled "Phase II Study of Dose-Adjusted EPOCH-Rituximab in Adults With Untreated Burkitt Lymphoma and c-MYC+ Diffuse Large B-Cell Lymphoma". Background: * Burkitt lymphoma/leukemia (BL) is highly treatable, but most of the standard therapies require multiple doses of intensive chemotherapy that may require long hospital stays and frequently have severe side effects. In addition, BL is a fairly common type of cancer in patients who also ...
What is the current status of trial NCT01092182?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 194 participants. The study started on 2010-03-25. Estimated completion is 2023-02-16.
What interventions are being tested in trial NCT01092182?
The interventions under investigation include: EPOCH-R (DRUG), EPOCH-RR (DRUG).
Who is sponsoring clinical trial NCT01092182?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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