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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 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.

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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.

Conditions Studied

Acute Myeloid Leukemia (AML)

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

FieldValue
Enrollment Target 36 participants
Start Date 2023-06-26
Est. Completion 2027-02
Phase Phase 1

Sponsor

Memorial Sloan Kettering Cancer Center

1,884 total trials

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What the Registry Record Tells You About NCT05756777

The ClinicalTrials.gov registry entry for NCT05756777 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 144-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (75% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.