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SNDX-5613 + Chemotherapy for Leukemia

Phase 1
Waitlist Available
Research Sponsored by Syndax Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have documented relapsed or refractory (R/R) AML, ALL, or acute leukemias of ambiguous lineage (ALAL) including MPAL and acute undifferentiated leukemia (AUL) harboring KMT2A rearrangement, KMT2A amplification, NPM1c, or NUP98r.
Participant must be taking 1 of the following medications for antifungal prophylaxis: itraconazole, ketoconazole, posaconazole, or voriconazole.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through up to 30 days after last dose of study intervention
Awards & highlights

Study Summary

This trial is testing a new drug, SNDX-5613, to see if it is safe and effective when given with chemotherapy to people with leukemia that has come back or does not respond to treatment.

Who is the study for?
This trial is for people with certain types of acute leukemia that have come back or haven't responded to treatment. They must be on specific antifungal meds, agree to contraception if they can have children, and have a white blood count under control. Good performance status and proper liver/heart function are required.Check my eligibility
What is being tested?
The study tests the safety of SNDX-5613 combined with two chemotherapy regimens in patients with relapsed/refractory acute leukemias who have specific genetic changes related to their cancer.See study design
What are the potential side effects?
While not specified here, common side effects from similar treatments may include nausea, fatigue, increased risk of infection due to low blood cell counts, hair loss from chemotherapy, and potential liver or heart issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My leukemia has returned or didn't respond to treatment and has specific genetic changes.
Select...
I am currently taking an antifungal medication like itraconazole.
Select...
I can take care of myself and perform daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through up to 30 days after last dose of study intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through up to 30 days after last dose of study intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Dose Limiting Toxicities From Revumenib
Number of Participants With Treatment-emergent Adverse Events
Secondary outcome measures
Area Under The Concentration Versus Time Curve From Time 0 To 24 Hours (AUC0-24) Of Revumenib
Area Under The Plasma Concentration Versus Time Curve From Time 0 To t (AUC0-t) Of Revumenib
Maximum Plasma Concentration (Cmax) of Revumenib

Trial Design

2Treatment groups
Experimental Treatment
Group I: Revumenib and Chemotherapy Regimen 2Experimental Treatment2 Interventions
Participants with ALL/MPAL or acute myeloid leukemia (AML) will receive revumenib every 12 hours in combination with 2 treatment cycles of Chemotherapy Regimen 2.
Group II: Revumenib and Chemotherapy Regimen 1Experimental Treatment2 Interventions
Participants with acute lymphoblastic leukemia/mixed phenotype acute leukemia (ALL/MPAL) will receive revumenib every 12 hours in combination with 2 treatment cycles of Chemotherapy Regimen 1.

Find a Location

Who is running the clinical trial?

Syndax PharmaceuticalsLead Sponsor
48 Previous Clinical Trials
2,786 Total Patients Enrolled
8 Trials studying Leukemia
601 Patients Enrolled for Leukemia
Nicole McNeer, MD, PhDStudy DirectorSyndax Pharmaceuticals
1 Previous Clinical Trials
8 Total Patients Enrolled
1 Trials studying Leukemia
8 Patients Enrolled for Leukemia
Nicole McNeer, M.D.Study DirectorSyndax Pharmaceuticals
1 Previous Clinical Trials
413 Total Patients Enrolled
1 Trials studying Leukemia
413 Patients Enrolled for Leukemia

Media Library

Chemotherapy Regimen 1 Clinical Trial Eligibility Overview. Trial Name: NCT05326516 — Phase 1
Leukemia Research Study Groups: Revumenib and Chemotherapy Regimen 2, Revumenib and Chemotherapy Regimen 1
Leukemia Clinical Trial 2023: Chemotherapy Regimen 1 Highlights & Side Effects. Trial Name: NCT05326516 — Phase 1
Chemotherapy Regimen 1 2023 Treatment Timeline for Medical Study. Trial Name: NCT05326516 — Phase 1

Frequently Asked Questions

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

How many participants are engaged in this clinical experimentation?

"Affirmative. According to the information found on clinicaltrials.gov, recruitment for this medical trial is ongoing since its initial posting date of March 9th 2022 and last updated on July 18th 2022. Currently, 54 participants are being sought from 2 participating facilities."

Answered by AI

Has the FDA sanctioned SNDX-5613 for use?

"Our team at Power scored SNDX-5613 with a 1 on the safety scale as this is an early Phase 1 trial, so there are limited published data to demonstrate its efficacy and security."

Answered by AI

Are there still vacancies available for volunteers in this clinical trial?

"Clinicaltrials.gov states that the study is actively searching for participants, with its initial posting being made on March 9th 2022 and a subsequent update occurring on July 18th 2022."

Answered by AI
~9 spots leftby May 2025