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NCT03547700 · ClinicalTrials.gov registry record · Phase 1
Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL)
A Phase 1 study of Lymphoma, T-Cell, Peripheral, sponsored by Ryan Wilcox.
- Active
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 7
- Study locations
NCT03547700: Active Phase 1 study of Lymphoma, T-Cell, Peripheral, sponsored by Ryan Wilcox.
NCT03547700 is a Phase 1 study of Lymphoma, T-Cell, Peripheral that is active but no longer recruiting, run by Ryan Wilcox. The registered enrollment target is 11 participants, below the 331-participant average among 6 other Lymphoma, T-Cell, Peripheral trials with a reported enrollment target (97% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03547700, a Phase 1 study of Lymphoma, T-Cell, Peripheral, is active but no longer recruiting, sponsored by Ryan Wilcox.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 7
- Study locations
Study Summary
Single arm phase I/II study of ixazomib and romidepsin in relapsed/refractory PTCL. Each cycle is 28 days. Patients will continue to receive therapy until progressive disease, unacceptable toxicity, or if any other withdrawal criteria are met. The phase I study includes three dose levels. The phase II study will include treatment with ixazomib and romidepsin at the MTD established in the Phase I study.
Primary Outcome
MTD is the dose level with a model-estimated rate of Dose Limiting Toxicities (DLT) closest to 25% after 36 patients have been enrolled. The maximum tolerated dose could not be determined because the trial was terminated early, however the number of participants who experienced DLTs found at each dose level is reported in a new outcome measure.
Conditions Studied
Interventions
- DRUG Romidepsin
- DRUG Ixazomib
Study Locations (7)
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
- Karmanos Cancer Center (Wayne State University) - Detroit
Illinois
- University of Illinois Cancer Center - Chicago
Indiana
- Indiana University Melvin and Bren Simon Cancer Center - Indianapolis
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Minnesota
- University of Minnesota - Minneapolis
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-09-26 |
| Est. Completion | 2021-07 |
| Phase | Phase 1 |
What the registry record for NCT03547700 still lists
NCT03547700 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 331-participant average among 6 other Lymphoma, T-Cell, Peripheral trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Lymphoma, T-Cell, Peripheral appearing as the primary indexed condition, and to 2 interventions - of which Romidepsin is the first listed.
NCT03547700 lists 7 locations in 6 states (Michigan, Illinois, Indiana).
Frequently Asked Questions
What is clinical trial NCT03547700 about?
NCT03547700 is a clinical study titled "Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL)". Single arm phase I/II study of ixazomib and romidepsin in relapsed/refractory PTCL. Each cycle is 28 days. Patients will continue to receive therapy until progressive disease, unacceptable toxicity, or if any other withdrawal criteria are met. The phase I study includes three dose levels. The phase ...
What is the current status of trial NCT03547700?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2018-09-26. Estimated completion is 2021-07.
What conditions does trial NCT03547700 study?
This clinical trial studies the following conditions: Lymphoma, T-Cell, Peripheral.
What interventions are being tested in trial NCT03547700?
The interventions under investigation include: Romidepsin (DRUG), Ixazomib (DRUG).
Who is sponsoring clinical trial NCT03547700?
This trial is sponsored by Ryan Wilcox, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03547700 being conducted?
This trial has 7 study locations across Illinois, Indiana, Iowa, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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