NCT05756777

A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)

A Phase 1b Multi-center Study of the FLT3 Inhibitor Gilteritinib in Combination With the IDH1 Inhibitor Ivosidenib or the IDH2 Inhibitor Enasidenib for Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Have Co-occurring FLT3/IDH1 or FLT3/IDH2 Mutations

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	Gilteritinib	Dose level (-1) 80mg, (1) 120mg, (2) 120mg
DRUG	Ivosidenib	Dose level (-1) 250mg, (1) 250mg, (2) 500mg
DRUG	Enasidenib	Dose level (-1) 50mg, (1) 50mg, (2) 100mg

Timeline

• Start date: 2023-06-26
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2023-03-06
• Last updated: 2026-03-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study