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NCT00001430 · ClinicalTrials.gov registry record · Phase 2
A Randomized Study of EPOCH II Versus EPOCH II and Immunotherapy in Lymphomas
A Phase 2 study of Non-Hodgkin's Lymphoma and Hodgkin's Disease, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
- 1
- Study location
NCT00001430: Completed Phase 2 study of Non-Hodgkin's Lymphoma and Hodgkin's Disease, sponsored by National Cancer Institute (NCI).
NCT00001430 is a Phase 2 study of Non-Hodgkin's Lymphoma and Hodgkin's Disease that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 49 participants, below the 221-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001430, a Phase 2 study of Non-Hodgkin's Lymphoma and Hodgkin's Disease, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized study of combination chemotherapy (EPOCH II) versus EPOCH II and immunotherapy with peripheral blood stem cells (PBSC) and IL-2 in patients with relapsed Hodgkin's and non-Hodgkin's lymphomas, and untreated patients with low-grade non-Hodgkin's lymphomas. The chemotherapy entails the administration of multiple cycles of infusional doxorubicin, etoposide and vincristine chemotherapy (total of 3), alternating with cycles of high-dose cyclophosphamide (3 cycles). Patients will be randomized, on a 2:1 basis, to either receive only chemotherapy or to undergo a PBSC harvest with PBSC reinfusion and IL-2 following the last cycle of chemotherapy. In all patients, immunological monitoring for NK/LAK activity, T cell number and function will be performed. The therapy is specifically targeted for patients who would be candidates for high-dose chemotherapy with stem cell support.
Conditions Studied
Interventions
- DRUG IL-2
- PROCEDURE PBSC
- DRUG EPOCH II
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 1995-02 |
| Est. Completion | 2002-01 |
| Phase | Phase 2 |
What the finished NCT00001430 record still lists
NCT00001430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 221-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Non-Hodgkin's Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which IL-2 is the first listed.
NCT00001430 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001430 about?
NCT00001430 is a clinical study titled "A Randomized Study of EPOCH II Versus EPOCH II and Immunotherapy in Lymphomas". This is a randomized study of combination chemotherapy (EPOCH II) versus EPOCH II and immunotherapy with peripheral blood stem cells (PBSC) and IL-2 in patients with relapsed Hodgkin's and non-Hodgkin's lymphomas, and untreated patients with low-grade non-Hodgkin's lymphomas. The chemotherapy entail...
What is the current status of trial NCT00001430?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 1995-02. Estimated completion is 2002-01.
What conditions does trial NCT00001430 study?
This clinical trial studies the following conditions: Non-Hodgkin's Lymphoma, Hodgkin's Disease.
What interventions are being tested in trial NCT00001430?
The interventions under investigation include: IL-2 (DRUG), PBSC (PROCEDURE), EPOCH II (DRUG).
Who is sponsoring clinical trial NCT00001430?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001430 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00001430's enrollment target sits among peer trials
49 30th of 63 higher than 34 of 63 other Non-Hodgkin's Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Hodgkin's Lymphoma 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.
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