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Anti-metabolites

ASTX727/venetoclax for Acute Myeloid Leukemia

Phase 1
Recruiting
Led By Branko Cuglievan, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to swallow pills
Age ≥2 years of age and ≤18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights

Study Summary

This trial aims to determine the appropriate dose of a drug combination, ASTX727 and venetoclax, for children with relapsed acute myeloid leukemia (AML).

Who is the study for?
This trial is for pediatric patients aged 2-18 with relapsed/refractory Acute Myeloid Leukemia. They must have a certain level of blasts in their blood or bone marrow, be able to swallow pills, and meet specific health criteria including liver and kidney function. Pregnant females can't participate, and all participants must agree to use contraception.Check my eligibility
What is being tested?
The study aims to find the right dose of ASTX727 combined with venetoclax for children who have AML that has come back after treatment or didn't respond to previous treatments. It's an early-phase trial focusing on dosage, safety, how the body processes the drugs (pharmacokinetics), and how they affect leukemia (pharmacodynamics).See study design
What are the potential side effects?
Potential side effects may include digestive issues, liver enzyme changes, fatigue due to low blood counts from chemotherapy-like effects on bone marrow; risk of infection; possible allergic reactions; and other organ-specific inflammation as seen with similar cancer therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow pills.
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I am between 2 and 18 years old.
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My kidney function tests are within the normal range for my age and sex.
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I can do most activities if I am under 16, or at least take care of myself if I am older.
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My child's AML has come back or didn't respond to treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 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
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Design

1Treatment groups
Experimental Treatment
Group I: ASTX727/venetoclaxExperimental Treatment2 Interventions
On Days 1-5 of Cycle 1, you will take ASTX727 by mouth with a glass of water. Participants must fast (not eat or drink anything but water, black coffee, or tea) for at least 2 hours before and for 2 hours after taking ASTX727. For 4 hours before dosing and 4 hours after dosing, participants should not take antacids or any other medicine that can change the amount of acid in your stomach. Days 1-21 or 1-28 depending on dose level, of all cycles beginning with Cycle 2. The study doctor will tell participants which of these schedules participants will follow. Venetoclax should be taken with water and a meal at around the same time each day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
ASTX727
2018
Completed Phase 3
~240

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,338 Total Patients Enrolled
Astex Pharmaceuticals, Inc.Industry Sponsor
95 Previous Clinical Trials
7,903 Total Patients Enrolled
Branko Cuglievan, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
100 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 positions for patients to participate in this clinical trial?

"According to the information available on clinicaltrials.gov, this particular clinical trial is not currently seeking participants. The trial was initially posted on February 29th, 2024, and the most recent update occurred on December 20th, 2023. However, it's important to note that there are currently 1483 other trials actively accepting participants at this time."

Answered by AI

Has the FDA granted approval for ASTX727/venetoclax as a treatment option?

"Based on the classification of this trial as a Phase 1 study, our team at Power rates the safety of ASTX727/venetoclax as a 1. This indicates that there is limited data available to support both its safety and efficacy."

Answered by AI

Is this medical study open to individuals who are older than 25 years of age?

"This clinical investigation aims to recruit individuals who are above 2 years old but below the age of 18."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase Ia/Ib Open-label, Multiple Dose, Study to Determine the Recommended Dose, Evaluate PKs, PDs, Safety, and Activity of Venetoclax in Combination With Oral Decitabine/Cedazuridine (ASTX727) in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)
2024. "A Phase Ia/Ib Open-label, Multiple Dose, Study to Determine the Recommended Dose, Evaluate PKs, PDs, Safety, and Activity of Venetoclax in Combination With Oral Decitabine/Cedazuridine (ASTX727) in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06191978.
~39 spots leftby Dec 2028
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