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Chemotherapy

All Eligible Participants for Acute Leukemia

Phase 1

Recruiting

Led By Jeffrey E. Rubnitz, MD, PhD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

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

Must have

Adequate organ function, defined as direct bilirubin ≤ 1.5 x institutional upper limit of normal, normal creatinine for age, and left ventricular ejection fraction ≥ 40%

Refractory leukemia, defined as persistent leukemia (≥1% blasts confirmed by flow cytometry or molecular testing) after at least two courses of induction chemotherapy, or relapsed leukemia, defined as the re-appearance of leukemia (≥1% blasts confirmed by flow cytometry or molecular testing) after the achievement of remission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is studying the safety and effectiveness of adding a new drug called revumenib to standard chemotherapy drugs for treating patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (

Who is the study for?

This trial is for young patients with a type of blood cancer called acute myeloid leukemia (AML) or ambiguous lineage leukemia that hasn't responded to treatment or has returned. Participants must be able to take an anti-fungal drug alongside the study medications.Check my eligibility

What is being tested?

The study is testing the combination of a new drug, Revumenib, with Azacitidine and Venetoclax in children and young adults. It aims to find out if this mix is safe and effective against relapsed or stubborn AML when taken with an anti-fungal medication.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system, liver problems, low blood cell counts leading to increased infection risk, bleeding issues, nausea, vomiting, diarrhea, fatigue and potential interactions with other drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver, kidneys, and heart are functioning within normal ranges.

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My leukemia has not responded to at least two treatments or has returned after remission.

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My cancer has a specific genetic change.

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I am between 1 and 30 years old.

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I am mostly active and can do most activities without help, regardless of my age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

The safety and tolerability of revumenib + azacitidine + venetoclax in pediatric patients with relapsed or refractory AML or ALAL

Secondary outcome measures

The overall survival of patients treated at the RP2D.

The rates of complete remission (CR)

The rates of complete remission with incomplete count recovery (CRi)

Trial Design

1Treatment groups

Experimental Treatment

Group I: All Eligible ParticipantsExperimental Treatment6 Interventions

All eligible patients receive the following intervention: Revumenib, Venetoclax, Azacitidine, Intrathecal chemotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

2012

Completed Phase 3

~1440

Cytarabine

2016

Completed Phase 3

~3310

Methotrexate

2013

Completed Phase 4

~3800

Venetoclax

2019

Completed Phase 3

~1990

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,589 Total Patients Enrolled

Syndax PharmaceuticalsIndustry Sponsor

48 Previous Clinical Trials

2,750 Total Patients Enrolled

Jeffrey E. Rubnitz, MD, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital

5 Previous Clinical Trials

384 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 there any available vacancies for potential participants in this research study?

"As per clinicaltrials.gov, this particular clinical trial is not currently seeking participants. The information indicates that it was initially posted on January 1st, 2024 and last updated on December 11th, 2023. However, there are presently a total of 1487 other ongoing clinical trials actively recruiting individuals for participation."

Answered by AI

Do all eligible participants meet the approval criteria set by the FDA?

"Based on the classification of this trial as Phase 1, which indicates limited data supporting safety and efficacy, our team at Power assigns a safety rating of 1 to all eligible participants."

Answered by AI

Which individuals would be more suitable candidates to participate in this clinical trial?

"To be eligible for this clinical trial, potential participants must have a diagnosis of acute leukemia and fall between the age range of 1 year to 30 years. The study aims to enroll approximately 24 individuals."

Answered by AI

Is the age criterion for potential participants in this medical study limited to those who are younger than 60 years old?

"To be considered for this clinical study, potential participants must fall within the age range of 1 year to 30. It is worth noting that there are a total of 456 ongoing trials specifically targeting individuals under the age of 18, and an additional 1183 trials focused on those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia

2024. "Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06177067.