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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05756777
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gilteritinib — DRUG
    Dose level (-1) 80mg, (1) 120mg, (2) 120mg
  • Ivosidenib — DRUG
    Dose level (-1) 250mg, (1) 250mg, (2) 500mg
  • Enasidenib — DRUG
    Dose level (-1) 50mg, (1) 50mg, (2) 100mg

Study Details

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.

Key Dates

Start date
Jun 26, 2023
Status verified
Mar 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: gilteritinib + ivosidenib (Cohort 1)
    Each patient will take the combination of gilteritinib/ ivosidenib (Cohort 1) , daily, in continuous 28-day cycles at the dose level that they are assigned.
  • Experimental: gilteritinib + enasidenib (Cohort 2)
    Each patient will take the combination of gilteritinib/enasidenib (Cohort 2) daily, in continuous 28-day cycles at the dose level that they are assigned.

Primary Outcome Measure

Determine the maximum tolerated dose (MTD) [ Time Frame: 1 year ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920
Eytan Stein, MD
646-608-3749
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748
Eytan Stein, MD
646-608-3749
Memorial Sloan Kettering BergenMontvaleNew Jersey07645
Eytan Stein, MD
646-608-3749
Memorial Sloan Kettering Suffolk-CommackCommackNew York11725
Eytan Stein, MD
646-608-3749
Memorial Sloan Kettering WestchesterHarrisonNew York10604
Eytan Stein, MD
646-608-3749
Eytan Stein, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Eytan Stein, MD
646-608-3749
Aaron Goldberg, MD, Phd
646-608-3752
Memorial Sloan Kettering NassauUniondaleNew York11553
Eytan Stein, MD
646-608-3749

Find similar trials in Basking Ridge, NJ

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Memorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Bergen· Montvale, NJMemorial Sloan Kettering Suffolk-Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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