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NCT02273102 · ClinicalTrials.gov registry record · Phase 1
Study of TCP-ATRA for Adult Patients With AML and MDS
A Phase 1 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT02273102 is a Phase 1 study that has completed, run by University of Miami. The registered enrollment target is 17 participants.
The verdict
NCT02273102, a Phase 1 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Acute Myeloid Leukemia (AML) is a diverse disease that is fatal in the majority of patients. Acute promyelocytic leukemia (APL) however, a subtype of AML accounting for 5% of all cases, is very curable. APL cells are highly sensitive to the retinoid all-trans-retinoic acid (ATRA), which effectively differentiates the leukemic clone. Over 80% of APL patients can be cured with ATRA based therapies. For patients with non-APL AML, ATRA has little effect. Consequently, 85% of these patients will succumb to their disease despite conventional approaches. Little is known about mechanisms of resistance to ATRA in non-APL AML. This knowledge gap limits the use of ATRA in a disease that already has few effective therapies. The investigators' preliminary data suggest that non-APL AML cells can be re-sensitized to ATRA when combined with lysine-specific demethylase 1 (LSD 1) inhibitors. The investigators' publication in Nature Medicine showed that LSD1 inhibition with tranylcypromine (TCP), unlocked the ATRA-driven therapeutic response in non-APL AML. Notably, treatment with ATRA and TCP markedly diminished the engraftment of primary human AML cells in murine models, indicating that the combination may target leukemia-initiating cells (LIC). The investigators' data identify LSD1 as a therapeutic target and strongly suggest that it may contribute to ATRA resistance in non-APL AML. The investigators' central hypothesis is that ATRA combined with TCP will be safe and effective in a clinical population, and that this approach will suppress LICs and restore myeloid differentiation programs in patients with non-APL AML. Testing this hypothesis with the phase I clinical trial outlined in this protocol, will establish a new treatment paradigm in AML and extend the important anti-cancer effects of ATRA to all AML subtypes.
Interventions
- DRUG Tretinoin
- DRUG Tranylcypromine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2015-03-02 |
| Est. Completion | 2020-07-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02273102
The ClinicalTrials.gov registry entry for NCT02273102 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tretinoin is the first listed.
NCT02273102 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02273102 about?
NCT02273102 is a clinical study titled "Study of TCP-ATRA for Adult Patients With AML and MDS". Acute Myeloid Leukemia (AML) is a diverse disease that is fatal in the majority of patients. Acute promyelocytic leukemia (APL) however, a subtype of AML accounting for 5% of all cases, is very curable. APL cells are highly sensitive to the retinoid all-trans-retinoic acid (ATRA), which effectively ...
What is the current status of trial NCT02273102?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2015-03-02. Estimated completion is 2020-07-01.
What interventions are being tested in trial NCT02273102?
The interventions under investigation include: Tretinoin (DRUG), Tranylcypromine (DRUG).
Who is sponsoring clinical trial NCT02273102?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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