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Nucleoside Analog

ASTX727 + Venetoclax + Gilteritinib for Acute Myeloid Leukemia

Q: What conditions does Gilteritinib help alleviate?

Gilteritinib is a common treatment for patients in the ipss risk category intermediate-2. This medication can also help treat other conditions such as refractory anemias, <a href="https://www.withpower.com/clinical-trials/muscular-dystrophy">muscular dystrophy</a>, and <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, myelocytic, acute.

Q: What is the total sample size for this clinical research?

According to the latest update on clinicaltrials.gov, this study is still seeking patients for participation. The trial was first announced on July 8th, 2021 and was last updated August 22nd, 2022. They are looking for 42 people total, across one site.

Q: Are we still looking for volunteers for this experiment?

The clinicaltrials.gov website reports that this study is open for recruitment and taking patients. The listing was first posted on 7/8/2021 with the most recent edit being on 8/22/2022.

Q: How does this Gilteritinib research fit into the current literature?

As of now, there are 324 Gilteritinib trials underway with 50 in Phase 3. Most studies for Gilteritinib are being conducted out of Toronto, Ontario; however, 9663 locations worldwide are running trials for Gilteritinib.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,304 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

Frequently Asked Questions

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

What conditions does Gilteritinib help alleviate?

"Gilteritinib is a common treatment for patients in the ipss risk category intermediate-2. This medication can also help treat other conditions such as refractory anemias, muscular dystrophy, and leukemia, myelocytic, acute."

Answered by AI

What is the total sample size for this clinical research?

"According to the latest update on clinicaltrials.gov, this study is still seeking patients for participation. The trial was first announced on July 8th, 2021 and was last updated August 22nd, 2022. They are looking for 42 people total, across one site."

Answered by AI

Are we still looking for volunteers for this experiment?

"The clinicaltrials.gov website reports that this study is open for recruitment and taking patients. The listing was first posted on 7/8/2021 with the most recent edit being on 8/22/2022."

Answered by AI

How does this Gilteritinib research fit into the current literature?

"As of now, there are 324 Gilteritinib trials underway with 50 in Phase 3. Most studies for Gilteritinib are being conducted out of Toronto, Ontario; however, 9663 locations worldwide are running trials for Gilteritinib."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

2021. "ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05010122.