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NCT02891278 · ClinicalTrials.gov registry record · Phase 1
Sertraline and Cytosine Arabinoside in Adults With Relapsed and Refractory AML
A Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02891278: Completed Phase 1 study, sponsored by Columbia University.
NCT02891278 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02891278, a Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a Phase I study with the goals of determining the feasibility, safety, and toxicity of administering sertraline in combination with timed-sequential cytosine arabinoside (ara-C) in adults with relapsed and refractory acute myeloid leukemia (AML). Primary objective: * To define the maximum tolerated dose (MTD) and Recommended Phase II Dose (RP2D) of sertraline administered in combination with timed-sequential cytosine arabinoside in adult patients with relapsed and refractory acute myeloid leukemia. * To evaluate the safety and tolerability of sertraline given in combination with timed-sequential cytosine arabinoside in adult patients with relapsed and refractory acute myeloid leukemia.
Primary Outcome
Standard 3+3 dose-escalation design will be used to determine the MTD. The MTD will be determined as the highest dose level where 1/6 patients experience dose-limiting toxicity (DLT). Three patients will be treated at a given dose level combination and observed for at least 4 weeks to assess toxicity. Doses will not be escalated in any individual patient.
Interventions
- DRUG Sertraline
- DRUG Cytosine arabinoside
- PROCEDURE allogeneic stem cell transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2016-08-11 |
| Est. Completion | 2020-11-17 |
| Phase | Phase 1 |
What the finished NCT02891278 record still lists
NCT02891278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Sertraline is the first listed.
NCT02891278 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02891278 about?
NCT02891278 is a clinical study titled "Sertraline and Cytosine Arabinoside in Adults With Relapsed and Refractory AML". This is a Phase I study with the goals of determining the feasibility, safety, and toxicity of administering sertraline in combination with timed-sequential cytosine arabinoside (ara-C) in adults with relapsed and refractory acute myeloid leukemia (AML). Primary objective: * To define the maximum ...
What is the current status of trial NCT02891278?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2016-08-11. Estimated completion is 2020-11-17.
What interventions are being tested in trial NCT02891278?
The interventions under investigation include: Sertraline (DRUG), Cytosine arabinoside (DRUG), allogeneic stem cell transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT02891278?
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 NCT02891278's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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