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NCT00139841 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab
A Phase 3 study, sponsored by Cephalon.
- Completed
- Registry status
- Phase 3
- Development phase
- 103
- Enrollment target
NCT00139841 is a Phase 3 study that has completed, run by Cephalon. The registered enrollment target is 103 participants.
The verdict
NCT00139841, a Phase 3 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 103 participants
- Enrollment target
Study Summary
SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. Following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.
Interventions
- DRUG Bendamustine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2005-10 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00139841
The ClinicalTrials.gov registry entry for NCT00139841 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 103 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 HCl is the first listed.
NCT00139841 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00139841 about?
NCT00139841 is a clinical study titled "Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab". SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given...
What is the current status of trial NCT00139841?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 103 participants. The study started on 2005-10. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00139841?
The interventions under investigation include: Bendamustine HCl (DRUG).
Who is sponsoring clinical trial NCT00139841?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
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