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NCT01458366 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT01458366 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 38 participants.
The verdict
NCT01458366, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
The Phase I part of the study will apply to identify dose-limiting toxicities (DLT) and to define maximum-tolerated dose (MTD) for a new chemoimmunotherapy combination of bendamustine, ofatumumab, carboplatin, and etoposide in patients with Non Hodgkin's lymphoma whose disease has progressed or has recurred after prior chemotherapy. The Phase II part of the study will be a single-arm, open-label study in which all patients will receive combination bendamustine, ofatumumab, carboplatin and etoposide at the MTD dose defined in phase I. This study hopes to identify a life-prolonging therapy for patients with Non-Hodgkin's Lymphoma whose disease has progressed or has recurred after prior chemotherapy. The hypothesis is that the proposed combination of chemotherapy is well-tolerated and is efficacious for the treatment of relapsed/refractory aggressive B cell lymphomas.
Interventions
- DRUG Carboplatin
- DRUG Etoposide
- DRUG Bendamustine
- PROCEDURE CT Scan
- DRUG Ofatumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2011-11-09 |
| Est. Completion | 2020-07-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01458366
The ClinicalTrials.gov registry entry for NCT01458366 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT01458366 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01458366 about?
NCT01458366 is a clinical study titled "Phase I/II Study of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide". The Phase I part of the study will apply to identify dose-limiting toxicities (DLT) and to define maximum-tolerated dose (MTD) for a new chemoimmunotherapy combination of bendamustine, ofatumumab, carboplatin, and etoposide in patients with Non Hodgkin's lymphoma whose disease has progressed or has ...
What is the current status of trial NCT01458366?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2011-11-09. Estimated completion is 2020-07-23.
What interventions are being tested in trial NCT01458366?
The interventions under investigation include: Carboplatin (DRUG), Etoposide (DRUG), Bendamustine (DRUG), CT Scan (PROCEDURE), Ofatumumab (DRUG).
Who is sponsoring clinical trial NCT01458366?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
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