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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 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 6 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02891278
The ClinicalTrials.gov registry entry for NCT02891278 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sertraline is the first listed.
NCT02891278 reports 0 study locations.
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.
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