Study Summary
This trial is to test a new cancer drug to see what dose is best and if it is effective and safe.
- Acute Leukemias of Ambiguous Lineage
- Acute Myeloid Leukemia
- Mixed Lineage Acute Leukemia
- Acute Lymphoblastic Leukemia
- Mixed Phenotype Acute Leukemia
Treatment Effectiveness
Effectiveness Progress
Study Objectives
16 Primary · 14 Secondary · Reporting Duration: Approximately 5 years
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Experimental: SNDX-5613
1 of 1
Experimental Treatment
440 Total Participants · 1 Treatment Group
Primary Treatment: SNDX-5613 · No Placebo Group · Phase 1 & 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age Any Age · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Sasca, Daniel, Borhane Guezguez, and Michael W.M. Kühn. 2021. “Next Generation Epigenetic Modulators to Target Myeloid Neoplasms”. Current Opinion in Hematology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/moh.0000000000000673.
- Jiménez, Jennifer A., April A. Apfelbaum, Allegra G. Hawkins, Laurie K. Svoboda, Abhijay Kumar, Ramon Ocadiz Ruiz, Alessandra X. Garcia, et al.. 2021. “EWS-FLI1 and Menin Converge to Regulate ATF4 Activity in Ewing Sarcoma”. Molecular Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1541-7786.mcr-20-0679.
- Jimenez JA, Apfelbaum AA, Hawkins AG, Svoboda LK, Kumar A, Ruiz RO, Garcia AX, Haarer E, Nwosu ZC, Bradin J, Purohit T, Chen D, Cierpicki T, Grembecka J, Lyssiotis CA, Lawlor ER. EWS-FLI1 and Menin Converge to Regulate ATF4 Activity in Ewing Sarcoma. Mol Cancer Res. 2021 Jul;19(7):1182-1195. doi: 10.1158/1541-7786.MCR-20-0679. Epub 2021 Mar 19.
- Sasca D, Guezguez B, Kuhn MWM. Next generation epigenetic modulators to target myeloid neoplasms. Curr Opin Hematol. 2021 Sep 1;28(5):356-363. doi: 10.1097/MOH.0000000000000673.
- 2019. "A Study of SNDX-5613 in R/R Leukemias Including Those With an MLLr/KMT2A Gene Rearrangement or NPM1 Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04065399.
Frequently Asked Questions
What are we hoping to learn from this experiment?
"The primary purpose of this one year long clinical trial is to evaluate the frequency and severity of adverse events. Additionally, the study will also focus on secondary objectives such as duration of response, apparent volume of distribution, and best overall remission rate." - Anonymous Online Contributor
Is this clinical trial widely available in Canada?
"Patients are able to enroll at Memorial Sloan Kettering Cancer Center in New York, The Hospital for Sick Children in Toronto, and Stanford Cancer Institute in Palo Alto among 16 other hospitals." - Anonymous Online Contributor
What is the maximum number of patients that can join this trial?
"Yes, as of today, this clinical trial is recruiting patients. This experiment was originally posted on November 5th, 2019 and the most recent update was on July 28th, 2022. There are 440 total participants being recruited from 16 different locations." - Anonymous Online Contributor
Are there opportunities for new patients to join this experiment?
"The trial, which was posted on November 5th 2019 and updated most recently on July 28th 2022, is looking for participants. This information comes from the clinicaltrials.gov website." - Anonymous Online Contributor
Could you please provide more context on SNDX-5613 research?
"SNDX-5613 was first studied 18 years ago at University of Zurich. Since then, there have been 90 completed trials with 9 more currently underway. The majority of these ongoing studies are based in New York City." - Anonymous Online Contributor