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Nucleoside Analog

ASTX727 + Venetoclax + Gilteritinib for Acute Myeloid Leukemia

Phase 1 & 2
Recruiting
Led By Farhad Ravandi-Kashani
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
Ability to swallow
Adults >= 18 years with relapsed/refractory FLT3-mutated AML or myelodysplastic syndrome (MDS) that is intermediate-2 or high-risk by the International Prognostic Scoring System (Phase I cohort)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing the combination of gilteritinib with ASTX727 and venetoclax to treat patients with FLT3-mutated acute myeloid leukemia or high-risk myelodysplastic syndrome.

Who is the study for?
Adults aged 18+ with FLT3-mutated acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS), either newly diagnosed, relapsed, or refractory. Participants must have adequate organ function and performance status <=3 on the ECOG scale. Exclusions include prior gilteritinib treatment, more than three lines of therapy for Phase II cohort B, serious infections, heart failure, CNS leukemia, HIV positivity, hepatitis B/C infection.Check my eligibility
What is being tested?
The trial is testing a combination of ASTX727 (decitabine and cedazuridine), venetoclax, and gilteritinib to determine the best dose and effect on AML/MDS with FLT3 mutation. The study aims to see if these drugs can control cancer growth by killing cells or stopping them from dividing/spreading.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system's response to the drugs causing inflammation in organs; gastrointestinal issues like nausea; blood-related problems such as anemia; liver enzyme alterations; fatigue; risk of infections due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow without any issues.
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I am an adult with AML or MDS, my condition is high-risk, and I have a FLT3 mutation.
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My leukemia has FLT3 mutations.
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I am an adult with AML or MDS, have a FLT3 mutation, and have had one prior therapy.
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I can take care of myself but can't do heavy physical work.
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I am an adult with AML or MDS, have a FLT3 mutation, and my condition is considered high-risk.
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My AML diagnosis is recent and has a FLT3 mutation.
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I am 75 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Maximum tolerated dose (Phase I)
Overall response (OR) rate (Phase II)
Secondary outcome measures
Complete response rate
Incidence of adverse events
Overall survival
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (decitabine, cedazuridine, venetoclax, gilteritib)Experimental Treatment3 Interventions
INDUCTION (CYCLE 1): Patients receive decitabine and cedazuridine PO QD on days 1-5, venetoclax PO QD on days 1-28, and gilteritinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity CONSOLIDATION (CYCLES 2-24): Patients receive decitabine and cedazuridine PO QD on days 1-5, gilteritinib PO QD on days 1-28, and venetoclax PO QD on days 1-21. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE (CYCLES 24+): Patients receive gilteritinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Gilteritinib
2014
Completed Phase 2
~560

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,999 Previous Clinical Trials
1,794,086 Total Patients Enrolled
Farhad Ravandi-KashaniPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
664 Total Patients Enrolled

Media Library

ASTX727 (Nucleoside Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05010122 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: Treatment (decitabine, cedazuridine, venetoclax, gilteritib)
Acute Myeloid Leukemia Clinical Trial 2023: ASTX727 Highlights & Side Effects. Trial Name: NCT05010122 — Phase 1 & 2
ASTX727 (Nucleoside Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05010122 — Phase 1 & 2
~7 spots leftby Jan 2025