Revumenib + Standard Treatments for Acute Myeloid Leukemia
Trial Summary
What is the purpose of this trial?
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)
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have taken strong CYP3A4 inducers within 7 days before starting the study. Also, drugs that prolong QTc should be avoided if possible.
What data supports the effectiveness of the drug combination Revumenib + Standard Treatments for Acute Myeloid Leukemia?
Research shows that about 50% to 75% of adults with acute myeloid leukemia achieve complete remission with cytarabine and an anthracycline like daunorubicin, which are part of the standard treatments. Additionally, new targeted agents like FLT3 inhibitors, which include midostaurin, have shown promise in improving outcomes for patients with specific genetic abnormalities.12345
Is the combination of Revumenib and standard treatments for Acute Myeloid Leukemia safe?
The combination of daunorubicin and cytarabine, used in treatments like Vyxeos, has been approved for certain types of Acute Myeloid Leukemia and has a known safety profile. Common side effects include rash, fever, fatigue, and low blood cell counts, which are similar to those seen with standard treatments. Always consult with a healthcare provider for personalized advice.13678
What makes the drug combination of Revumenib, Cytarabine, Daunorubicin, and Midostaurin unique for treating acute myeloid leukemia?
This drug combination is unique because it includes Revumenib, a novel agent, alongside standard chemotherapy drugs Cytarabine and Daunorubicin, and the FLT3 inhibitor Midostaurin, which targets specific genetic mutations in acute myeloid leukemia, potentially offering a more tailored and effective treatment approach.39101112
Research Team
Richard Stone, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive induction chemotherapy with revumenib, cytarabine, daunorubicin, and midostaurin to induce remission
Reinduction Cycle
Participants may receive a second cycle of induction therapy if needed
Consolidation Cycle
Participants receive consolidation chemotherapy to maintain remission
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cytarabine (Antineoplastic Agent)
- Daunorubicin (Antineoplastic Agent)
- Midostaurin (FLT3 Inhibitor)
- Revumenib (Menin Inhibitor)
Cytarabine is already approved in Canada for the following indications:
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Chronic myeloid leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Maximilian Stahl, MD
Lead Sponsor
Richard Stone, MD
Lead Sponsor
Syndax Pharmaceuticals
Industry Sponsor