SNDX-5613 for Leukemias

Phase-Based Progress Estimates
David H Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, NYLeukemias+3 MoreSNDX-5613 - Drug
Any Age
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Relapsed/Refractory Leukemias
  • Mixed Phenotype Acute Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Day 1 through up to 30 days after last dose of study intervention

Day 30
Number of Participants With Dose Limiting Toxicities From SNDX-5613
Number of Participants With Treatment-emergent Adverse Events
Hour 6
Area Under The Concentration Versus Time Curve From Time 0 To 24 Hours (AUC0-24) Of SNDX-5613
Area Under The Plasma Concentration Versus Time Curve From Time 0 To t (AUC0-t) Of SNDX-5613
Maximum Plasma Concentration (Cmax) Of SNDX-5613

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

SNDX-5613 and Chemotherapy Regimen 2
1 of 2
SNDX-5613 and Chemotherapy Regimen 1
1 of 2

Experimental Treatment

54 Total Participants · 2 Treatment Groups

Primary Treatment: SNDX-5613 · No Placebo Group · Phase 1

SNDX-5613 and Chemotherapy Regimen 2Experimental Group · 2 Interventions: SNDX-5613, Chemotherapy Regimen 2 · Intervention Types: Drug, Drug
SNDX-5613 and Chemotherapy Regimen 1Experimental Group · 2 Interventions: Chemotherapy Regimen 1, SNDX-5613 · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 through up to 30 days after last dose of study intervention

Who is running the clinical trial?

Syndax PharmaceuticalsLead Sponsor
41 Previous Clinical Trials
2,482 Total Patients Enrolled
Nicole McNeer, MD, PhDStudy DirectorSyndax Pharmaceuticals
Nicole McNeer, M.D.Study DirectorSyndax Pharmaceuticals
1 Previous Clinical Trials
440 Total Patients Enrolled
Kate Madigan, M.D.Study DirectorSyndax Pharmaceuticals, Inc.
1 Previous Clinical Trials
8 Total Patients Enrolled
Michael Meyers, M.D.Study DirectorSyndax Pharmaceuticals, Inc.

Eligibility Criteria

Age Any Age · All Participants · 7 Total Inclusion Criteria

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Frequently Asked Questions

How many participants are engaged in this clinical experimentation?

"Affirmative. According to the information found on, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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

" 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.