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Epigenetic Modifiers
SNDX-5613 for Acute Leukemia (AUGMENT-101 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Syndax Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cohort 2C: Documented R/R AML with NPM1c.
Arm B: Participants receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis.
Must not have
Cirrhosis with a Child-Pugh score of B or C.
Isolated extramedullary relapse.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights
Summary
This trial is to test a new cancer drug to see what dose is best and if it is effective and safe.
Who is the study for?
This trial is for individuals with relapsed/refractory acute leukemias, specifically those with MLL rearrangement or NPM1 mutation. Participants must have a white blood cell count below 25,000/microliter and resolved prior treatment toxicities to ≤Grade 1 (except neuropathy or alopecia). They should not be on certain antifungal drugs unless specified in the study arms, have no active central nervous system disease, HIV viral load, hepatitis B/C, significant cardiac issues within the last six months, severe gastrointestinal conditions affecting drug absorption or serious graft-versus-host disease.Check my eligibility
What is being tested?
The trial tests SNDX-5613 alone or combined with cobicistat to determine its maximum tolerated dose and efficacy in treating specific types of leukemia. Phase 1 focuses on dosage while Phase 2 evaluates effectiveness and safety across different patient groups defined by their genetic mutations related to leukemia.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with leukemia treatments may include fatigue, nausea/vomiting, diarrhea/constipation, risk of infection due to low blood counts (neutropenia), bleeding/bruising from low platelet counts (thrombocytopenia), anemia causing tiredness and shortness of breath.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My AML has relapsed or is resistant, and tests show NPM1c mutation.
Select...
I am taking strong antifungal medication like itraconazole.
Select...
I am not taking any medication that strongly affects liver enzymes.
Select...
I have active acute leukemia with specific genetic changes.
Select...
My leukemia has a specific genetic change known as MLLr.
Select...
My AML cancer has a specific genetic change known as MLLr.
Select...
It's been over 14 days or 5 half-lives since my last leukemia treatment.
Select...
I am not taking strong CYP3A4 inhibitors/inducers or fluconazole.
Select...
I am mostly active and can care for myself.
Select...
I am currently taking fluconazole.
Select...
I am taking isavuconazole for fungal infection prevention.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My liver disease is severe, as indicated by my Child-Pugh score.
Select...
My cancer has returned outside the bone marrow.
Select...
I have been diagnosed with acute promyelocytic leukemia.
Select...
I have active brain or spinal cord disease confirmed by tests.
Select...
I have hepatitis B or C.
Select...
I have no upper GI issues affecting drug absorption.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUC0-t (Phase 1)
CR+CRh rate (Phase 2)
Cmax (Phase 1)
+4 moreSecondary outcome measures
AUC0-t (Phase 2)
CRc rate (Phase 2)
Cmax (Phase 2)
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: RevumenibExperimental Treatment2 Interventions
Phase 1: Oral revumenib; sequential cohorts of escalating dose levels of revumenib to identify the MTD and RP2D. Participants will be enrolled in 1 of 6 dose-escalation arms:
Arm A: Participants not receiving any strong CYP3A4 inhibitor/inducers or fluconazole
Arm B: Participants receiving any strong CYP3A4 inhibitors for antifungal prophylaxis
Arm C: Participants receiving revumenib and cobicistat
Arm D: Participants receiving fluconazole for antifungal prophylaxis
Arm E: Participants not receiving any weak, moderate, or strong CYP3A4 inhibitors/inducers
Arm F: Participants receiving isavuconazole for antifungal prophylaxis
Phase 2: Oral revumenib; Following the determination of the RP2D in Phase 1, 3 indication-specific expansion cohorts will be enrolled as follows:
Cohort 2A: Participants with KMT2Ar ALL/MPAL
Cohort 2B: Participants with KMT2Ar AML
Cohort 2C: Participants with NPM1m AML
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cobicistat
2012
Completed Phase 1
~140
Find a Location
Who is running the clinical trial?
Syndax PharmaceuticalsLead Sponsor
48 Previous Clinical Trials
2,403 Total Patients Enrolled
Angie Smith, M.D.Study DirectorSyndax Pharmaceuticals
Galit Rosen, M.D.Study DirectorSyndax Pharmaceuticals, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My AML has relapsed or is resistant, and tests show NPM1c mutation.My liver disease is severe, as indicated by my Child-Pugh score.I am taking strong antifungal medication like itraconazole.I am not taking any medication that strongly affects liver enzymes.I have active acute leukemia with specific genetic changes.My cancer has returned outside the bone marrow.I am not on medications that significantly affect heart rhythm, except for certain allowed drugs.I have been diagnosed with acute promyelocytic leukemia.It's been over 60 days since my last major radiation therapy or 14 days since any small, local radiation.I haven't had severe GVHD symptoms or been on strong immune-suppressing drugs for 4 weeks.I am taking SNDX-5613 with cobicistat.My leukemia has a specific genetic change known as MLLr.My side effects from previous treatments are mild, except for possible nerve pain or hair loss.I haven't had a heart attack, severe heart issues, or a stroke in the last 6 months.I haven't taken strong steroids for more than a week, or only take a low dose daily.I haven't had any cancer except for certain skin cancers or early-stage cancers treated with curative intent in the last 2 years.My AML cancer has a specific genetic change known as MLLr.It's been over 14 days or 5 half-lives since my last leukemia treatment.It's been over a week since I last took short-acting blood cell boosters, and over two weeks for long-acting ones.I am not taking strong CYP3A4 inhibitors/inducers or fluconazole.I have a heart condition.I have a gastrointestinal condition.It's been over 90 days or 5 half-lives since my last biologic cancer treatment.My treatment is in Phase 2.It's been over 60 days since my stem cell transplant and over 4 weeks since my donor lymphocyte infusion.I am mostly active and can care for myself.I am currently taking fluconazole.I have active brain or spinal cord disease confirmed by tests.I have hepatitis B or C.It's been over 42 days since my last immunotherapy and over 21 days since any T cell therapy.My white blood cell count is below 25,000/microliter.I am at least 30 days old.I am considering joining the first phase of a clinical trial.I am taking isavuconazole for fungal infection prevention.My organs are working well.I have no upper GI issues affecting drug absorption.
Research Study Groups:
This trial has the following groups:- Group 1: Revumenib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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