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Epigenetic Modulator

SNDX-5613 for Acute Myeloid Leukemia

Phase 1

Recruiting

Research Sponsored by Syndax Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through 30 days after final dose (up to approximately 3 years)

Awards & highlights

Study Summary

This trial aims to assess how safe and effective SNDX-5613 is when used with strong chemotherapy in individuals who have just been diagnosed with a type of blood cancer called acute myeloid leukemia (

Who is the study for?

This trial is for adults with newly diagnosed acute myeloid leukemia (AML) who have specific genetic changes (KMT2A, NPM1, or NUP98 mutations) and can handle intensive chemotherapy. They should be in decent physical shape (ECOG ≤2), have good liver, kidney, and heart function, and not have been treated for AML before.Check my eligibility

What is being tested?

The study tests SNDX-5613 combined with a strong chemotherapy regimen called HiDAC to see how safe it is and how well it works against AML. Researchers will monitor participants' reactions to the treatment and check its effectiveness in patients with certain gene alterations.See study design

What are the potential side effects?

Possible side effects of SNDX-5613 when used with intensive chemo may include typical chemo-related issues like nausea, fatigue, hair loss; plus any unique reactions related to SNDX-5613 which will be closely monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through 30 days after final dose (up to approximately 3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through 30 days after final dose (up to approximately 3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through 30 days after final dose (up to approximately 3 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Escalation: Number of Participants with Dose-limiting Toxicities

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Secondary outcome measures

AUC0-t of SNDX-5613 and Relevant Metabolites

Area Under the Plasma Concentration Versus Time Curve From Time 0 to t (AUC0-t) of SNDX-5613 and Relevant Metabolites

Cmax of SNDX-5613 and Relevant Metabolites

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: SNDX-5613Experimental Treatment3 Interventions

Dose Escalation: Induction: Sequential cohorts of escalating dose levels of SNDX-5613 with chemotherapy regimen. Consolidation: Cohorts will receive high-dose cytarabine (HiDAC) chemotherapy followed by SNDX-5613. Maintenance Monotherapy: Cohorts will receive SNDX-5613. Dose Expansion: Induction: SNDX-5613 at tolerated dose level with chemotherapy regimen. Consolidation: Cohorts will receive SNDX-5613 with chemotherapy regimen and HiDAC. Maintenance Monotherapy: Cohorts will receive SNDX-5613.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemotherapy Regimen

2008

Completed Phase 3

~340

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Syndax PharmaceuticalsLead Sponsor

48 Previous Clinical Trials

2,698 Total Patients Enrolled

Frequently Asked Questions

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

Is there an age criterion specifying patients below 60 years old for eligibility into this medical research study?

"Individuals aged between 18 and 75 are eligible for participation in this research study. Notably, there are a substantial number of clinical trials available for participants under 18 years old (482 trials) and those over the age of 65 (1220 trials)."

Answered by AI

What is the total number of participants being recruited for this research study?

"Indeed, as per clinicaltrials.gov, this current trial is actively seeking participants. The study was originally published on March 1st, 2024 and last revised on March 22nd, 2024. Recruitment aims to include a total of 76 patients from one specific site."

Answered by AI

Are researchers actively seeking participants for this study at the moment?

"Indeed, the details on clinicaltrials.gov highlight that this investigation is actively enrolling volunteers. The trial was initially disclosed on March 1st, 2024, and underwent its latest update on March 22nd, 2024. A total of 76 participants are being sought at a single site for this study."

Answered by AI

Which individuals are eligible to partake in this experimental study?

"Seeking 76 individuals aged between 18 and 75 diagnosed with acute myeloid leukemia, fulfilling specific conditions is paramount. These requirements encompass sufficient liver, kidney, and heart function; a confirmed AML diagnosis as per the World Health Organization's criteria of 2022; no prior treatment for AML with eligibility for aggressive chemotherapy; an Eastern Cooperative Oncology Group performance status equal to or less than 2 (or less than or equal to 1 if over the age of 65); and identification of KMT2Ar, NPM1c, or NUP98r mutations by a local laboratory before initial SNDX-"

Answered by AI

Has the drug SNDX-5613 received approval from the FDA?

"Given that this trial is in Phase 1, indicating limited safety and effectiveness data, SNDX-5613 has been assigned a safety rating of 1 by our team at Power."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

2024. "A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06226571.