Revumenib in Combination With 7+3 + Midostaurin in AML

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Richard Stone, MD
Study ID
NCT06313437
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Revumenib — DRUG
    Menin inhibitor, 25 and 113 mg capsules, taken orally per protocol.
  • Midostaurin — DRUG
    Kinase inhibitor, capsule taken orally per protocol.
  • Cytarabine — DRUG
    Antineoplastic agent, via intravenous (into the vein) infusion per protocol.
  • Daunorubicin — DRUG
    Antineoplastic agent, via intravenous (into the vein) infusion per protocol.

Study Details

This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction (initial therapy to induce a remission) + FLT3 targeted therapy (midostaurin) and a single cycle of post-remission therapy + FLT3 targeted therapy (midostaurin) to participants with newly diagnosed Nucleophosmin (NPM1) and FMS-like tyrosine kinase 3 (FLT3) mutated Acute Myeloid Leukemia (AML). The names of the study drugs involved in this study are: * Revumenib (SNDX-5613) (a type of menin inhibitor) * Midostaurin (a type of multi-kinase including FLT3 inhibitor) * Cytarabine (a type of antineoplastic agent) * Daunorubicin (a type of antineoplastic agent)

Key Dates

Start date
Dec 6, 2024
Status verified
Mar 2026
Primary completion
Mar 2, 2027
Completion
Mar 2, 2028

Study Design

Enrollment
22 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Revumenib
    Standard 3+3 design for a recommended phase 2 dose of Revumenib per dose-limiting toxicity rules. Cycles are 28 days. * Baseline * Induction Cycle: * Days 1-3: Predetermined dose of Daunorubicin 1x daily * Days 1-7: Predetermined dose of Cytarabine * Days 8-21: Predetermined dose of Midostaurin 2x daily * Days 8-28: Predetermined dose of Revumenib 2x daily * End of Induction visit * Follow-up * Reinduction Cycle: Therapy will be administered in the hospital * Days 1-2: Predetermined dose of Daunorubicin 1x daily * Days 1-5: Predetermined dose of Cytarabine * Days 8-21: Predetermined dose of Midostaurin 2x daily * Days 8-28: Predetermined dose of Revumenib 2x daily * End of reinduction visit * Follow-up * Consolidation Cycle: Therapy will be administered in the hospital * Days 1, 3, and 5: Predetermined dose of Cytarabine * Days 8-21: Predetermined dose of Midostaurin 2x daily * Days 8-28: Predetermined dose of Revumenib 2x daily * End of consolidation visit * Follow up
  • Experimental: Dose-Expansion Revumenib
    Cycles are 28 days * Baseline visit and assessments * Induction Cycle: * Days 1-3: Predetermined dose of Daunorubicin 1x daily * Days 1-7: Predetermined dose of Cytarabine * Days 8-21: Predetermined dose of Midostaurin 2x daily * Days 8-28: Predetermined dose of Revumenib 2x daily * End of Induction visit * Follow-up * Reinduction Cycle: Therapy will be administered in the hospital * Days 1-2: Predetermined dose of Daunorubicin 1x daily * Days 1-5: Predetermined dose of Cytarabine * Days 8-21: Predetermined dose of Midostaurin 2x daily * Days 8-28: Predetermined dose of Revumenib 2x daily * End of Reinduction visit * Follow-up * Consolidation Cycle: Therapy will be administered in the hospital * Days 1, 3, and 5: Predetermined dose of Cytarabine * Days 8-21: Predetermined dose of Midostaurin 2x daily * Days 8-28: Predetermined dose of Revumenib 2x daily * End of Consolidation visit * Follow up

Primary Outcome Measure

Number of Participants Experiencing Dose Limiting Toxicity (DLT) [ Time Frame: Up to 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06150
Maximilian Stahl, MD
[email protected]
Dana-Farber Cancer InstituteBostonMassachusetts02215
Richard Stone, MD
[email protected]
617-632-5157
Richard Stone, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Yale Cancer Center· New Haven, CTDana-Farber Cancer Institute· Boston, MA

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