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NCT00114738 · ClinicalTrials.gov registry record · Phase 2
EPOCH-R Chemotherapy Plus Bortezomib to Treat Mantle Cell Lymphoma
A Phase 2 study of Mantle Cell Lymphoma and Lymphoma, Mantle-Cell, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 1
- Study location
NCT00114738: Completed Phase 2 study of Mantle Cell Lymphoma and Lymphoma, Mantle-Cell, sponsored by National Cancer Institute (NCI).
NCT00114738 is a Phase 2 study of Mantle Cell Lymphoma and Lymphoma, Mantle-Cell that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 53 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00114738, a Phase 2 study of Mantle Cell Lymphoma and Lymphoma, Mantle-Cell, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the effectiveness of etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin-rituximab (EPOCH-R) chemotherapy plus bortezomib for treating mantle cell lymphoma, a cancer of white blood cells called lymphocytes. EPOCH-R consists of the drugs prednisone, etoposide, doxorubicin and vincristine, with the addition of a new drug called rituximab. In a recent study of patients with newly diagnosed mantle cell lymphoma, 92 percent had a complete remission of their disease after treatment with EPOCH-R. This study will test whether adding bortezomib as "maintenance therapy" once chemotherapy is finished will lengthen the time before the disease relapses and improve the overall cure rate. Patients 18 years of age and older with mantle cell lymphoma may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram, multi-gated acquisition scan (MUGA) or echocardiogram, imaging studies and biopsy to determine the extent of disease, and possible colonoscopy. Participants undergo treatment in three parts, as follows: * Part 1: Bortezomib alone: Patients receive 4 doses of bortezomib over 3 weeks. The drug is injected into a vein over about 30 seconds. * Part 2: EPOCH-R chemotherapy plus bortezomib: This phase of treatment begins 3 to 4 weeks after completing Part 1. Treatment is given on an outpatient basis in six 3-week cycles, with all drugs administered over the first 5 days of each cycle. Patients take prednisone by mouth on days 1 to 5 and etoposide, doxorubicin, and vincristine as a 96-hour infusion through a vein over days 1 to 5. The infused drugs are delivered through a lightweight, portable infusion pump. Rituximab is given by vein over several hours on day 1 immediately before the chemotherapy infusion begins. Bortezomib is given by vein over 30 seconds on day 1 before the rituximab and again on day 4. Cyclophosphamide is given by vein over about 15 minu
Conditions Studied
Interventions
- DRUG Bortezomib
- DRUG Rituximab (R)
- BIOLOGICAL EPOCH
- DRUG Bortezomib (B)
- DRUG Bortezomib or observation
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2005-06-15 |
| Est. Completion | 2022-08-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00114738
The ClinicalTrials.gov registry entry for NCT00114738 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (49% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Bortezomib is the first listed.
NCT00114738 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00114738 about?
NCT00114738 is a clinical study titled "EPOCH-R Chemotherapy Plus Bortezomib to Treat Mantle Cell Lymphoma". This study will evaluate the effectiveness of etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin-rituximab (EPOCH-R) chemotherapy plus bortezomib for treating mantle cell lymphoma, a cancer of white blood cells called lymphocytes. EPOCH-R consists of the drugs prednisone, etoposide, d...
What is the current status of trial NCT00114738?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2005-06-15. Estimated completion is 2022-08-11.
What conditions does trial NCT00114738 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma, Lymphoma, Mantle-Cell.
What interventions are being tested in trial NCT00114738?
The interventions under investigation include: Bortezomib (DRUG), Rituximab (R) (DRUG), EPOCH (BIOLOGICAL), Bortezomib (B) (DRUG), Bortezomib or observation (DRUG).
Who is sponsoring clinical trial NCT00114738?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00114738 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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