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Antineoplastic Agent

Revumenib + Standard Treatments for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Research Sponsored by Maximilian Stahl, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing different doses of a drug called Revumenib in combination with standard treatments for Acute Myeloid Leukemia in patients with specific genetic mutations. The study is looking to find

Who is the study for?

This trial is for people newly diagnosed with a specific type of blood cancer called Acute Myeloid Leukemia (AML) that has certain genetic changes (NPM1 and FLT3 mutations). Participants should be starting their first treatment.

What is being tested?

The study is testing the safety and effectiveness of a new drug, Revumenib, when used with standard AML treatments Midostaurin, Cytarabine, and Daunorubicin. The goal is to find the best dose of Revumenib in this combination.

What are the potential side effects?

Possible side effects include reactions at the infusion site, nausea, vomiting, diarrhea, heart problems due to Midostaurin; low blood cell counts leading to infection or bleeding risks from Cytarabine and Daunorubicin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD)

Number of Participants Experiencing Dose Limiting Toxicity (DLT)

Recommended phase II dose (RP2D)

Secondary study objectives

Complete Remission (CR) rate with consolidation chemotherapy

Complete Remission (CR) rate with induction chemotherapy

Flow Measurable Residual Disease Negative (MRD-) rate with consolidation chemotherapy

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose-Expansion RevumenibExperimental Treatment4 Interventions

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

Group II: Dose Escalation RevumenibExperimental Treatment4 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Midostaurin

2018

Completed Phase 3

~1640

Cytarabine

2016

Completed Phase 3

~3330