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NCT05756777 · ClinicalTrials.gov registry record · Phase 1
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
A Phase 1 study of Acute Myeloid Leukemia (AML), sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 7
- Study locations
NCT05756777: Recruiting Phase 1 study of Acute Myeloid Leukemia (AML), sponsored by Memorial Sloan Kettering Cancer Center.
NCT05756777 is a Phase 1 study of Acute Myeloid Leukemia (AML) that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 36 participants, below the 144-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (75% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05756777, a Phase 1 study of Acute Myeloid Leukemia (AML), is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 7
- Study locations
Study Summary
The researchers are doing this study to see if the combination of gilteritinib with ivosidenib or enasidenib is a safe and effective treatment for people with relapsed/refractory AML with FLT3/IDH1 or FLT3/IDH2 gene mutations. The researchers will also look for the highest dose of the combination of gilteritinib with ivosidenib or enasidenib that causes few or mild side effects. When the highest safe dose is found, they will test that dose in new groups of participants.
Primary Outcome
These are derived based on Dose Limiting Toxicities (DLT) according to BOIN dose escalation methodology.
Conditions Studied
Interventions
- DRUG Gilteritinib
- DRUG Ivosidenib
- DRUG Enasidenib
Study Locations (7)
New York
- Memorial Sloan Kettering Suffolk-Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering Nassau - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Monmouth - Middletown
- Memorial Sloan Kettering Bergen - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-06-26 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
What NCT05756777 shows while recruiting
NCT05756777 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 144-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 3 interventions - of which Gilteritinib is the first listed.
NCT05756777 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT05756777 about?
NCT05756777 is a clinical study titled "A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)". The researchers are doing this study to see if the combination of gilteritinib with ivosidenib or enasidenib is a safe and effective treatment for people with relapsed/refractory AML with FLT3/IDH1 or FLT3/IDH2 gene mutations. The researchers will also look for the highest dose of the combination of...
What is the current status of trial NCT05756777?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2023-06-26. Estimated completion is 2027-02.
What conditions does trial NCT05756777 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML).
What interventions are being tested in trial NCT05756777?
The interventions under investigation include: Gilteritinib (DRUG), Ivosidenib (DRUG), Enasidenib (DRUG).
Who is sponsoring clinical trial NCT05756777?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05756777 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia (AML)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05756777's enrollment target sits among peer trials
36 22nd of 29 higher than 7 of 29 other Acute Myeloid Leukemia (AML) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia (AML) 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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