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NCT07283094 · ClinicalTrials.gov registry record · Phase 1
FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT07283094: Recruiting Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Montefiore Medical Center.
NCT07283094 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 33 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07283094, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, uncontrolled, single-arm, open-label, nonrandomized, dose escalation, study of Decitabine (DAC)+Venetoclax (VEN)+FHD-286 in participants with newly diagnosed Acute Myeloid Leukemia (AML) classified as adverse risk per the 2022 European Leukemia Net (ELN) criteria or AML that has progressed after one prior line of therapy.
Primary Outcome
Dose limiting toxicity is defined as any adverse event (AE) that occurs during the DLT evaluation period that also meets any one of the criteria for hematologic and non-hematologic AEs as defined by the protocol and determined by the Data and Safety Monitoring Committee (DSMC), with input from the clinical study team. All AEs that cannot clearly be determined to be unrelated to FHD-286 or the combination of FHD-286 with DAC and VEN will be considered relevant to determining DLTs and any other e
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Decitabine
- DRUG FHD-286
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2026-02-03 |
| Est. Completion | 2030-02 |
| Phase | Phase 1 |
What NCT07283094 shows while recruiting
NCT07283094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (72% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT07283094 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07283094 about?
NCT07283094 is a clinical study titled "FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia". This is a Phase 1, uncontrolled, single-arm, open-label, nonrandomized, dose escalation, study of Decitabine (DAC)+Venetoclax (VEN)+FHD-286 in participants with newly diagnosed Acute Myeloid Leukemia (AML) classified as adverse risk per the 2022 European Leukemia Net (ELN) criteria or AML that has p...
What is the current status of trial NCT07283094?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2026-02-03. Estimated completion is 2030-02.
What conditions does trial NCT07283094 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome.
What interventions are being tested in trial NCT07283094?
The interventions under investigation include: Venetoclax (DRUG), Decitabine (DRUG), FHD-286 (DRUG).
Who is sponsoring clinical trial NCT07283094?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07283094 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT07283094's enrollment target sits among peer trials
33 196th of 306 higher than 109 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
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