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NCT02187133 · ClinicalTrials.gov registry record · Phase 1
Carfilzomib With Bendamustine and Rituximab in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
A Phase 1 study of Lymphoma and Lymphoma, Non-Hodgkin, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 3
- Study locations
NCT02187133: Completed Phase 1 study of Lymphoma and Lymphoma, Non-Hodgkin, sponsored by University of California, San Francisco.
NCT02187133 is a Phase 1 study of Lymphoma and Lymphoma, Non-Hodgkin that has completed, run by University of California, San Francisco. The registered enrollment target is 10 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02187133, a Phase 1 study of Lymphoma and Lymphoma, Non-Hodgkin, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will be conducted as a Phase Ib, open-label, non-randomized, single-institution study to evaluate the safety and tolerability of carfilzomib in combination with bendamustine and rituximab in patients with relapsed or refractory NHL and to determine the recommended phase II dose and preliminary efficacy of this combination. The study will have two phases: a dose-escalation phase to determine the maximal tolerated dose of carfilzomib in this combination where participants will be monitored for toxicity, tolerability and response and a dose-expansion phase that will determine the preliminary efficacy in patients with Mantle cell lymphoma or any other disease subtype in which there is a preliminary efficacy signal observed.
Primary Outcome
The MTD will be the dose level immediately preceding the dose level at which \>= 2 Dose Limiting Toxicities (DLT) are observed and at which 0/3 or 1/6 participants experiences a DLT.
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Carfilzomib
- DRUG Bendamustine
Study Locations (3)
California
- University of California, Davis - Davis
- University of California, San Diego - San Diego
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-05-05 |
| Est. Completion | 2021-03-31 |
| Phase | Phase 1 |
What the finished NCT02187133 record still lists
NCT02187133 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Rituximab is the first listed.
NCT02187133 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02187133 about?
NCT02187133 is a clinical study titled "Carfilzomib With Bendamustine and Rituximab in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma". This study will be conducted as a Phase Ib, open-label, non-randomized, single-institution study to evaluate the safety and tolerability of carfilzomib in combination with bendamustine and rituximab in patients with relapsed or refractory NHL and to determine the recommended phase II dose and prelim...
What is the current status of trial NCT02187133?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2015-05-05. Estimated completion is 2021-03-31.
What conditions does trial NCT02187133 study?
This clinical trial studies the following conditions: Lymphoma, Lymphoma, Non-Hodgkin.
What interventions are being tested in trial NCT02187133?
The interventions under investigation include: Rituximab (DRUG), Carfilzomib (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT02187133?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02187133 being conducted?
This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02187133's enrollment target sits among peer trials
10 276th of 299 higher than 20 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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