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NCT00069238 · ClinicalTrials.gov registry record · Phase 2
Campath-1H and EPOCH to Treat Non-Hodgkin's T- and NK-Cell Lymphomas
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT00069238: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00069238 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 31 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00069238, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
Background: The paradigm of combining therapeutic agents with non-overlapping toxicities for the treatment of malignancy produces clinical remissions and cures in a number of tumor types. A new class of agents, humanized and chimerized monoclonal antibodies, typically have little or no hematopoietic toxicity and can be readily combined with full doses of cytotoxic chemotherapy. It has become clear that in certain lymphomas and breast cancers, the combination of monoclonal antibodies and chemotherapy improves response rate and the quality of the response compared with that achieved by treatment with either agent alone. The clinical outcome for patients with T-cell non-Hodgkins lymphoma is significantly inferior to the outcome of patients with B-cell non-Hodgkin s lymphoma. In most reports less than 20% of patients with T cell lymphoid malignancies remain free of disease at 5 years. Objectives: Determine the toxicity of Alemtuzumab and etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy in untreated cluster of differentiation 52 (CD52)-expressing T and natural killer (NK) lymphoid malignancies. Determine the maximum tolerated dose of Alemtuzumab administered in combination with EPOCH chemotherapy. Determine in a preliminary fashion the anti-tumor activity of the combination of Alemtuzumab and EPOCH chemotherapy. Eligibility: CD52-expressing lymphoid malignancy. Patients with chemotherapy naive aggressive T \& NK lymphomas. Patients with alk-positive anaplastic large cell lymphoma and patients with T cell precursor disease are not eligible. Age greater than or equal to 17 years. Adequate organ function, unless impairment due to respective organ involvement by tumor. No active symptomatic ischemic heart disease, myocardial infarction or congestive heart. failure within the past year. Human immunodeficiency virus (HIV) negative. Not pregnant or nursing. Design: Three dose levels of Alemtuzumab will be evaluated to deter
Interventions
- DRUG EPOCH
- BIOLOGICAL Alemtuzumab (Campath)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2003-09-19 |
| Est. Completion | 2021-03-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00069238
The ClinicalTrials.gov registry entry for NCT00069238 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 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 is the first listed.
NCT00069238 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00069238 about?
NCT00069238 is a clinical study titled "Campath-1H and EPOCH to Treat Non-Hodgkin's T- and NK-Cell Lymphomas". Background: The paradigm of combining therapeutic agents with non-overlapping toxicities for the treatment of malignancy produces clinical remissions and cures in a number of tumor types. A new class of agents, humanized and chimerized monoclonal antibodies, typically have little or no hematopoiet...
What is the current status of trial NCT00069238?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2003-09-19. Estimated completion is 2021-03-17.
What interventions are being tested in trial NCT00069238?
The interventions under investigation include: EPOCH (DRUG), Alemtuzumab (Campath) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00069238?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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