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Anti-cancer Drug

Treatment (revumenib, daunorubicin, cytarabine) for Acute Myeloid Leukemia

Q: Are individuals above the age of 18 eligible for participation in this trial?

To be eligible for this research study, participants must be between 18 and 75 years old.

Q: Are participants currently being recruited for enrollment in this clinical trial?

Information available on clinicaltrials.gov shows that this investigation is presently seeking suitable participants. The trial's initial posting was on November 10, 2024, and its latest revision took place on March 8, 2024.

Q: What is the upper limit of participants involved in this clinical study?

Yes, as per the details on clinicaltrials.gov, this research is presently enrolling participants. It was initially posted on November 10th, 2024 and last modified on March 8th, 2024. The study aims to enlist 28 individuals at a single site.

Q: Is it possible for me to participate in this medical study?

This clinical trial aims to recruit 28 individuals aged between 18 and 75 who are currently diagnosed with acute myeloid <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>. Eligible participants should meet the subsequent criteria: Suitable for intensive induction chemotherapy, have specific genetic mutations related to <a href="https://www.withpower.com/clinical-trials/aml">AML</a>, possess a performance status within defined limits, exhibit normal liver and kidney function as well as viral infection control, including <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a> treatment adherence and undetectable HBV or HCV viral loads if applicable; also allowed are patients with non-interfering prior malignancies.

Q: What are the potential risks associated with administration of revumenib, daunorubicin, and cytarabine as a treatment option for individuals?

Given that this is a Phase 1 trial with sparse safety and efficacy data, the Power team ranks the safety of Treatment (revumenib, daunorubicin, cytarabine) at level 1.

Phase 1

Recruiting

Led By Alice S Mims

Research Sponsored by National Cancer Institute (NCI)

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 baseline to cycle 1, day 2 at pre-treatment, 0.5, 1.0, 2.0, 4.0, 8.0 hours (hr); cycle 1 day 3 at 12 hr; cycle 1 day 15 at pre-treatment, 0.5, 1.0, 2.0, 4.0, and 8.0 hr

Awards & highlights

Study Summary

"This trial is testing the safety and effectiveness of a new drug called SNDX-5613 in combination with standard chemotherapy for treating patients with a specific type of leukemia. SNDX-5613 works by

Who is the study for?

This trial is for adults aged 18-75 with newly diagnosed acute myeloid leukemia that has specific gene changes (NPM1 or MLL/KMT2A) and are fit for intensive chemotherapy. Participants must have good organ function, an ECOG performance status of <=2, and if HIV-positive, they need undetectable viral load on effective therapy. Those with chronic hepatitis B or C must be on suppressive therapy or cured.Check my eligibility

What is being tested?

The trial is testing the safety and optimal dose of SNDX-5613 added to standard chemo drugs Daunorubicin and Cytarabine in patients with certain genetic types of acute myeloid leukemia. The goal is to see if this new combination can better shrink or control cancer compared to standard treatment alone.See study design

What are the potential side effects?

Potential side effects include those typical of chemotherapy like fatigue, nausea, hair loss, increased risk of infection due to low blood cell counts, as well as any unknown risks associated with the new drug SNDX-5613.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1, day 2 at pre-treatment, 0.5, 1.0, 2.0, 4.0, 8.0 hours (hr); cycle 1 day 3 at 12 hr; cycle 1 day 15 at pre-treatment, 0.5, 1.0, 2.0, 4.0, and 8.0 hr

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1, day 2 at pre-treatment, 0.5, 1.0, 2.0, 4.0, 8.0 hours (hr); cycle 1 day 3 at 12 hr; cycle 1 day 15 at pre-treatment, 0.5, 1.0, 2.0, 4.0, and 8.0 hr

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1, day 2 at pre-treatment, 0.5, 1.0, 2.0, 4.0, 8.0 hours (hr); cycle 1 day 3 at 12 hr; cycle 1 day 15 at pre-treatment, 0.5, 1.0, 2.0, 4.0, and 8.0 hr for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum tolerated dose (MTD) for Consolidation

Maximum tolerated dose (MTD) for Induction

Recommended phase 2 dose for expansion cohort

Secondary outcome measures

Complete response/complete response with incomplete count recovery (CR/Cri) rate

Pharmacokinetics (PK) of revumenib (SNDX-5613)

Other outcome measures

Best response overall

Best response to Induction

Changes in OATP1B and CYP3A biomarkers

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (revumenib, daunorubicin, cytarabine)Experimental Treatment8 Interventions

See Detailed Description.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

2016

Completed Phase 3

~3310

Biospecimen Collection

2004

Completed Phase 2

~1700

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Daunorubicin

2013

Completed Phase 4

~4940

Transthoracic Echocardiography

2016

N/A

~360

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,413 Total Patients Enrolled

Alice S MimsPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO

1 Previous Clinical Trials

13 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals above the age of 18 eligible for participation in this trial?

"To be eligible for this research study, participants must be between 18 and 75 years old."

Answered by AI

Are participants currently being recruited for enrollment in this clinical trial?

"Information available on clinicaltrials.gov shows that this investigation is presently seeking suitable participants. The trial's initial posting was on November 10, 2024, and its latest revision took place on March 8, 2024."

Answered by AI

What is the upper limit of participants involved in this clinical study?

"Yes, as per the details on clinicaltrials.gov, this research is presently enrolling participants. It was initially posted on November 10th, 2024 and last modified on March 8th, 2024. The study aims to enlist 28 individuals at a single site."

Answered by AI

Is it possible for me to participate in this medical study?

"This clinical trial aims to recruit 28 individuals aged between 18 and 75 who are currently diagnosed with acute myeloid leukemia. Eligible participants should meet the subsequent criteria: Suitable for intensive induction chemotherapy, have specific genetic mutations related to AML, possess a performance status within defined limits, exhibit normal liver and kidney function as well as viral infection control, including HIV treatment adherence and undetectable HBV or HCV viral loads if applicable; also allowed are patients with non-interfering prior malignancies."

Answered by AI

What are the potential risks associated with administration of revumenib, daunorubicin, and cytarabine as a treatment option for individuals?

"Given that this is a Phase 1 trial with sparse safety and efficacy data, the Power team ranks the safety of Treatment (revumenib, daunorubicin, cytarabine) at level 1."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene

2024. "Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05886049.