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Antineoplastic Agent

Dose Escalation Revumenib for 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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Number of Participants Experiencing Dose Limiting Toxicity (DLT)
Recommended phase II dose (RP2D)
Secondary outcome measures
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

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
~3310
Daunorubicin
2013
Completed Phase 4
~4940

Find a Location

Who is running the clinical trial?

Syndax PharmaceuticalsIndustry Sponsor
48 Previous Clinical Trials
2,752 Total Patients Enrolled
8 Trials studying Leukemia
609 Patients Enrolled for Leukemia
Maximilian Stahl, MDLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the objectives of this particular research endeavor?

"The primary objective of this research endeavor, spanning up to a 12-week period, is to evaluate the incidence of Dose Limiting Toxicity (DLT) among the study participants. Secondary endpoints encompass determining the rate at which patients achieve Measurable Residual Disease Negative (MRD-) status following induction and consolidation chemotherapy using flow cytometry for MRD assessment. Additionally, another secondary endpoint involves assessing Molecular Measurable Residual Disease Negative (MRD-) rates post-induction chemotherapy through NPM1 and FLT3 ITD MRD testing alongside duplex sequencing methodologies."

Answered by AI

Is the process of enrolling participants currently underway for this clinical trial?

"Information available on clinicaltrials.gov reveals that this particular research project is presently not accepting new participants. Initially listed on 9/1/2024 and last revised on 3/10/2024, the study has concluded recruitment efforts. Nonetheless, there are currently 1551 alternative trials actively seeking eligible candidates for participation."

Answered by AI

What are the safety considerations for patients undergoing Dose Escalation Revumenib treatment?

"Our team at Power rated the safety level of Dose Escalation Revumenib as 1 on a scale from 1 to 3. This trial falls under Phase 1, indicating that there is minimal existing data supporting both safety and efficacy."

Answered by AI

Can individuals such as myself participate in this clinical study?

"To qualify for this trial, participants must have a diagnosis of acute myeloid leukemia and fall between the ages of 18 and 75. The study aims to enroll approximately 22 individuals."

Answered by AI

Are individuals aged 75 and older eligible to participate in this study?

"In this research study, participation is open to individuals over 18 years of age and under the age of 75."

Answered by AI
~15 spots leftby Mar 2026