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NCT02181218 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Romidepsin, Gemcitabine, Oxaliplatin, and Dexamethasone in Patients With Relapsed/Refractory Aggressive Lymphomas
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02181218: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT02181218 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02181218, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this research study is to find the maximum tolerated dose of a drug called romidepsin when given with a treatment regimen called GemOxD. GemOxD is a routine treatment for certain types of lymphoma, and involves the administration of three drugs: gemcitabine, oxaliplatin, and dexamethasone. In addition to finding the maximum tolerated dose of romidepsin, the investigators want to look at the side effects of these drugs when given together, as well as how the lymphoma responds to this treatment.
Primary Outcome
Three participants will be treated at each dose level. If 0/3 patients experience dose limiting toxicity (DLT), 3 patients will be treated at the next dose level. If a DLT attributable to the treatment is experienced in 1 of 3 patients, three more patients (for a total of six participants) will be treated at that dose level. If no additional DLTs are observed at the expanded dose level (i.e. 1 of 6 with DLT), the dose will be escalated. Escalation will terminate as soon as two or more participan
Interventions
- DRUG Oxaliplatin
- DRUG Dexamethasone
- DRUG Gemcitabine
- DRUG Romidepsin
- DRUG Pegfilgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-02-04 |
| Est. Completion | 2020-06-26 |
| Phase | Phase 1 |
What the finished NCT02181218 record still lists
NCT02181218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 5 interventions - of which Oxaliplatin is the first listed.
NCT02181218 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02181218 about?
NCT02181218 is a clinical study titled "Phase I Study of Romidepsin, Gemcitabine, Oxaliplatin, and Dexamethasone in Patients With Relapsed/Refractory Aggressive Lymphomas". The purpose of this research study is to find the maximum tolerated dose of a drug called romidepsin when given with a treatment regimen called GemOxD. GemOxD is a routine treatment for certain types of lymphoma, and involves the administration of three drugs: gemcitabine, oxaliplatin, and dexametha...
What is the current status of trial NCT02181218?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2015-02-04. Estimated completion is 2020-06-26.
What interventions are being tested in trial NCT02181218?
The interventions under investigation include: Oxaliplatin (DRUG), Dexamethasone (DRUG), Gemcitabine (DRUG), Romidepsin (DRUG), Pegfilgrastim (DRUG).
Who is sponsoring clinical trial NCT02181218?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02181218's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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