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NCT00076349 · ClinicalTrials.gov registry record · Phase 2
SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)
A Phase 2 study, sponsored by Cephalon.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT00076349 is a Phase 2 study that has completed, run by Cephalon. The registered enrollment target is 66 participants.
The verdict
NCT00076349, a Phase 2 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study Summary
SUMMARY: This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if tumor status improves and there are no unacceptable side effects. Patients will be followed for up to 2 years or until disease progression. RATIONALE: Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkin's lymphoma patients. PURPOSE: This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.
Interventions
- DRUG bendamustine and rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2004-04 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00076349
The ClinicalTrials.gov registry entry for NCT00076349 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cephalon, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which bendamustine and rituximab is the first listed.
NCT00076349 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00076349 about?
NCT00076349 is a clinical study titled "SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)". SUMMARY: This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if tumor status...
What is the current status of trial NCT00076349?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2004-04. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00076349?
The interventions under investigation include: bendamustine and rituximab (DRUG).
Who is sponsoring clinical trial NCT00076349?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
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