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Nucleoside Analog

ASTX727 + Venetoclax for Acute Myeloid Leukemia

Phase 1 & 2

Waitlist Available

Research Sponsored by Taiho Oncology, Inc.

Eligibility Criteria Checklist

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

Must have

Participants must be considered ineligible for intensive induction chemotherapy defined by the following: a) Age 75 years or older, or b) Age 18 to 74 years with at least one of the following comorbidities: i) Severe cardiac disorder (eg, congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina), ii) Severe pulmonary disorder (eg, diffusing lung capacity for carbon monoxide DLCO ≤65% or forced expiratory volume in 1 second [FEV1] ≤65%), iii) Creatinine clearance ≥30 mL/min to <45 mL/min, iv) Moderate hepatic impairment with total bilirubin >1.5 to ≤3.0 × upper limit of normal (ULN), v) Phase 1: Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 (participants with ECOG ≥3 are not eligible); Phase 2, Parts A and B: ECOG Performance Status of 2 or 3 (participants with ECOG 4 are not eligible)

Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG]) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening

Must not have

Chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications that in the opinion of the investigator would adversely affect his/her participating in this study

Known or suspected hypersensitivity to decitabine, cedazuridine, venetoclax, or any of their excipients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination therapy for AML in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. The goal is to see if the therapy is safe and works well together.

Who is the study for?

Adults diagnosed with newly identified acute myeloid leukemia (AML) who are either 75 years or older, or between 18 to 74 with certain health issues that make intensive chemotherapy unsuitable. Participants must have a life expectancy of at least three months and be able to give informed consent. Women must not be pregnant and participants should agree to use effective contraception.

What is being tested?

The trial is testing the combination of ASTX727 (Decitabine and Cedazuridine) with Venetoclax in AML patients. It's designed in two phases: Phase 1 checks for drug interactions, while Phase 2 evaluates how well this combination works against AML.

What are the potential side effects?

Potential side effects may include digestive problems, blood disorders, fatigue, liver issues, infections due to weakened immune system response, allergic reactions to medication components, and possibly others depending on individual patient responses.

Eligibility Criteria

Inclusion Criteria

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

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I am not eligible for intensive chemotherapy due to my age or health conditions.

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I am not pregnant or breastfeeding and my pregnancy test was negative.

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I am 18 years old or older.

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My diagnosis of AML is confirmed by the latest WHO criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any major health issues that would affect my participation in the study.

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I am allergic to decitabine, cedazuridine, venetoclax, or their ingredients.

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My liver is not working well, with high bilirubin or enzyme levels.

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My leukemia is sensitive to a specific treatment due to certain genetic changes.

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My heart condition limits my physical activity beyond basic tasks.

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I have a history of blood disorders such as myelofibrosis or chronic leukemia.

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I can stop taking certain medications that affect how drugs are processed in my body for 7 days or 5 half-lives before starting the trial.

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I cannot stop taking medication that affects how my body processes drugs.

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I have been treated with specific drugs or therapies for my blood disorder.

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I cannot take medicine by mouth due to a digestive issue.

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My acute myeloid leukemia has spread to my brain or spinal cord.

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My kidney function is severely impaired.

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I do not have an uncontrolled infection needing treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Response (CR)

Secondary study objectives

Complete response (CR)

Duration of Response

Overall Survival

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Oral administration of ASTX727 and Venetoclax combinationExperimental Treatment2 Interventions

Cycle 1: ASTX727 according to a prescribed dosing regimen and venetoclax on day 1 (100 mg daily), day 2 (200 mg daily), and days 3-28 (400 mg daily) of a 28-day cycle. Cycle 2 and beyond: ASTX727 according to a prescribed dosing regimen and venetoclax on days 1-28 (400 mg daily) of a 28-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2240

0 / 17Eligibility criteria met