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NCT01998035 · ClinicalTrials.gov registry record · Phase 1
Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies
A Phase 1 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
NCT01998035: Clinical Trial Phase 1 study, sponsored by Columbia University.
NCT01998035 is a Phase 1 study that was terminated before completion, run by Columbia University. The registered enrollment target is 58 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01998035, a Phase 1 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
Study Summary
This is an open label, phase I/IIa, 3 x 3 dose escalation study with an initial phase I followed by a disease focused phase II. The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. The safety and toxicity of this combination will be evaluated throughout the entire study. If the combination of oral 5-azacitidine and romidepsin is found to be feasible and an MTD is established, the phase II part of the study will be initiated. Phase II will consist of a 2 stage design of the combination of oral 5-azacitidine and romidepsin for patients with relapsed or refractory T-cell lymphomas.
Primary Outcome
The highest dose of a drug or treatment that does not cause unacceptable side effects. The MTD is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found.
Interventions
- DRUG RomiDEPsin 10 MG/M2
- DRUG Oral 5-Azacitidine 100 MG
- DRUG Romidepsin 14 MG/M2
- DRUG Oral 5-Azacitidine 200 MG
- DRUG Oral 5-Azacitidine 300 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2013-11 |
| Est. Completion | 2020-01-06 |
| Phase | Phase 1 |
Why NCT01998035 stopped before completion
NCT01998035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which RomiDEPsin 10 MG/M2 is the first listed.
NCT01998035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01998035 about?
NCT01998035 is a clinical study titled "Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies". This is an open label, phase I/IIa, 3 x 3 dose escalation study with an initial phase I followed by a disease focused phase II. The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romide...
What is the current status of trial NCT01998035?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2013-11. Estimated completion is 2020-01-06.
What interventions are being tested in trial NCT01998035?
The interventions under investigation include: RomiDEPsin 10 MG/M2 (DRUG), Oral 5-Azacitidine 100 MG (DRUG), Romidepsin 14 MG/M2 (DRUG), Oral 5-Azacitidine 200 MG (DRUG), Oral 5-Azacitidine 300 MG (DRUG).
Who is sponsoring clinical trial NCT01998035?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01998035's enrollment target sits among peer trials
58 895th of 2000 higher than 1,100 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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