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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: Completed Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine the maximum-tolerated dose of bendamustine in combination with ofatumumab, carboplatin and etoposide for patients with refractory or relapsed aggressive B cell lymphomas. Toxicity levels will be assessed after every cycle until a dose-limiting toxicity (DLT) is found. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria (CTCAE version 4.0). DLT will be defined as any grade 4 infection, or grade \>/= 3 non-hematologic toxicity that persists
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 |
What the finished NCT01458366 record still lists
NCT01458366 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT01458366 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01458366's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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