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Chemotherapy
Revumenib + Chemotherapy for Acute Myeloid Leukemia
Memphis, TN
Phase 1
Recruiting
Led By Hiroto Inaba, MD, PhD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate organ function, defined as direct bilirubin ≤ 1.5 x institutional upper limit of normal, normal creatinine for age, and left ventricular ejection fraction ≥ 40%
Refractory leukemia, defined as persistent leukemia (≥1% blasts confirmed by flow cytometry or molecular testing) after at least two courses of induction chemotherapy, or relapsed leukemia, defined as the re-appearance of leukemia (≥1% blasts confirmed by flow cytometry or molecular testing) after the achievement of remission
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying the safety and effectiveness of adding a new drug called revumenib to standard chemotherapy drugs for treating patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (
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Who is the study for?
This trial is for young patients with a type of blood cancer called acute myeloid leukemia (AML) or ambiguous lineage leukemia that hasn't responded to treatment or has returned. Participants must be able to take an anti-fungal drug alongside the study medications.Check my eligibility
What is being tested?
The study is testing the combination of a new drug, Revumenib, with Azacitidine and Venetoclax in children and young adults. It aims to find out if this mix is safe and effective against relapsed or stubborn AML when taken with an anti-fungal medication.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system, liver problems, low blood cell counts leading to increased infection risk, bleeding issues, nausea, vomiting, diarrhea, fatigue and potential interactions with other drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver, kidneys, and heart are functioning within normal ranges.
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My leukemia has not responded to at least two treatments or has returned after remission.
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My cancer has a specific genetic change.
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I am between 1 and 30 years old.
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I am mostly active and can do most activities without help, regardless of my age.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The safety and tolerability of revumenib + azacitidine + venetoclax in pediatric patients with relapsed or refractory AML or ALAL
Secondary study objectives
The overall survival of patients treated at the RP2D.
The rates of complete remission (CR)
The rates of complete remission with incomplete count recovery (CRi)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: All Eligible ParticipantsExperimental Treatment6 Interventions
All eligible patients receive the following intervention:
Revumenib, Venetoclax, Azacitidine, Intrathecal chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Revumenib
2022
Completed Phase 1
~40
Venetoclax
2019
Completed Phase 3
~2290
Azacitidine
2014
Completed Phase 3
~1470
Cytarabine
2016
Completed Phase 3
~4020
Methotrexate
2019
Completed Phase 4
~4400
Find a Location
Closest Location:St. Jude Children's Research Hospital· Memphis, TN· 509 miles
Who is running the clinical trial?
Syndax PharmaceuticalsIndustry Sponsor
48 Previous Clinical Trials
2,696 Total Patients Enrolled
St. Jude Children's Research HospitalLead Sponsor
450 Previous Clinical Trials
5,326,437 Total Patients Enrolled
Hiroto Inaba, MD, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital
4 Previous Clinical Trials
914 Total Patients Enrolled
Jeffrey E. Rubnitz, MD, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital
5 Previous Clinical Trials
384 Total Patients Enrolled