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Hypomethylation Agent

Decitabine + Cedazuridine + Venetoclax for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Led By Michael R Savona
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
Adverse risk AML per 2017 European LeukemiaNet (ELN) recommendations
Recovery to =< grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying the effects of a combination of drugs on patients with higher-risk acute myeloid leukemia who do not have a change in the FLT3 gene. The drugs in the combination are decitabine, cedazuridine, and venetoclax. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is an enzyme inhibitor. It helps to increase the amount of decitabine in the body so that the medication will have a greater effect.

Who is the study for?
This trial is for adults aged 18-65 with higher-risk acute myeloid leukemia (AML) who haven't had certain previous treatments. Participants must have an ECOG performance status of <=2, no FLT3 gene mutations, and adequate organ function. They should not be pregnant or breastfeeding and must agree to use contraception.Check my eligibility
What is being tested?
The study tests ASTX727 (oral decitabine + cedazuridine) combined with venetoclax in AML patients without the FLT3 mutation. It aims to confirm if this combination is as safe as intravenous decitabine with venetoclax, potentially improving treatment for high-risk AML.See study design
What are the potential side effects?
Potential side effects include fatigue, nausea, liver issues, blood cell count changes leading to increased infection risk or bleeding problems. There may also be reactions related to bone marrow procedures like pain or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My AML is considered high-risk according to 2017 ELN guidelines.
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I have recovered from side effects of previous treatments, except for hair loss.
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My heart pumps blood well, with an ejection fraction of 50% or higher.
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I have had a bone marrow test to collect tissue for this trial.
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I can take care of myself but might not be able to do active work.
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I agree to use birth control during and after the study as required.
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I am between 18 and 65 years old and can meet all study requirements.
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My hepatitis B virus is under control with treatment.
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My diagnosis of AML is confirmed by specific tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Event-free survival (EFS) (Phase II)
Incidence of adverse events (Phase Ib)
Recommended safe phase 2 dose (RP2D) of decitabine and cedazuridine (ASTX727) in combination with venetoclax (Phase Ib)
Secondary outcome measures
Complete response rate (Phase II)
Duration of response (Phase II)
Mutational burdens in venetoclax + ASTX727 sensitive vs. resistant AML leukemia initiating cells (LICs) (Phase II)
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Phase Ib (decitabine and cedazuridine, venetoclax)Experimental Treatment4 Interventions
Patients receive ASTX727 PO QD on days 1-4 or 1-5 of each cycle and venetoclax PO QD on days 1-28 or days 1-21 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy and collection of blood samples throughout the trial.
Group II: Arm I (decitabine and cedazuridine, venetoclax)Experimental Treatment4 Interventions
Patients receive ASTX727 PO QD at the recommended phase II dose and venetoclax PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy and collection of blood samples throughout the trial.
Group III: Arm II (cytarabine, daunorubicin)Active Control3 Interventions
Patients receive cytarabine IV over 24 hours on days 1-7 of each cycle and daunorubicin IV over 10-30 minutes on days 1-3 of each cycle. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,098 Total Patients Enrolled
Michael R SavonaPrincipal InvestigatorYale University Cancer Center LAO

Media Library

Decitabine and Cedazuridine (Hypomethylation Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04817241 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: Phase Ib (decitabine and cedazuridine, venetoclax), Arm I (decitabine and cedazuridine, venetoclax), Arm II (cytarabine, daunorubicin)
Acute Myeloid Leukemia Clinical Trial 2023: Decitabine and Cedazuridine Highlights & Side Effects. Trial Name: NCT04817241 — Phase 1 & 2
Decitabine and Cedazuridine (Hypomethylation Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04817241 — 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 are Decitabine and Cedazuridine most often used as treatments for?

"The most common course of treatment for patients in ipss risk category intermediate-2 is Decitabine and Cedazuridine. However, Decitabine and Cedazuridine have also been shown to be useful for patients with refractory anemias, leukemia, myelocytic, acute, and blast phase chronic myelocytic leukemia."

Answered by AI

Could you please list Decitabine and Cedazuridine's clinical trial history?

"Decitabine and Cedazuridine are being researched in 549 separate clinical trials, with 103 of those research projects in Phase 3.While some of the trials for Decitabine and Cedazuridine are finishing in Toronto, Ontario, there are a total of 19804 locations conducting clinical trials for Decitabine and Cedazuridine."

Answered by AI

Are patients over the age of 65 eligible to enroll in this clinical trial?

"This study's age requirements for participation are that potential patients must be between 18-65 years old."

Answered by AI

Are there any restrictions for volunteers in this experiment?

"This study is seeking 18 patients with myeloid or leukemia that are aged 18-65. Key requirements for participants are as follows: Being between 18-65 years old at the time of signing the Informed Consent Form, Being able to meet all study requirements, A bone marrow aspirate and biopsy that has been performed recently, ECOG performance status of 2 or less, Recovery from any prior toxicities, WBC lower than 25000, Direct bilirubin lower than 2x the institutional ULN, AST/ALT lower than 3x the institutional ULN."

Answered by AI

Are we still recruiting for this particular research project?

"Yes, this is an active recruitment trial, which was first announced on August 2nd, 2021. The most recent update was on September 15th, 2022. The goal is to enroll 18 patients at 3 different sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination With Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients
2022. "Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination With Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04817241.
~6 spots leftby Aug 2024
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