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Nucleoside Analog
ASTX727 + Venetoclax for Acute Myeloid Leukemia
Phase 1 & 2
Waitlist Available
Research Sponsored by Astex Pharmaceuticals, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am not eligible for intensive chemotherapy due to my age or health conditions.
Select...
I am not pregnant or breastfeeding and my pregnancy test was negative.
Select...
I am 18 years old or older.
Select...
My diagnosis of AML is confirmed by the latest WHO criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response (CR)
Secondary outcome measures
Complete response (CR)
Duration of Response
Overall Survival
+10 moreTrial 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
~1990
Find a Location
Who is running the clinical trial?
Astex Pharmaceuticals, Inc.Lead Sponsor
95 Previous Clinical Trials
7,773 Total Patients Enrolled
Kim-Hien Dao, DO, PhDStudy DirectorAstex Pharmaceuticals, Inc.
2 Previous Clinical Trials
318 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not eligible for intensive chemotherapy due to my age or health conditions.You cannot have eaten grapefruit, grapefruit products, Seville oranges, or starfruit within a week before the start of the trial.I do not have any major health issues that would affect my participation in the study.I am allergic to decitabine, cedazuridine, venetoclax, or their ingredients.I have an active hepatitis B or C infection.I am not pregnant or breastfeeding and my pregnancy test was negative.I am 18 years old or older.You are expected to live for at least 3 more months.My liver is not working well, with high bilirubin or enzyme levels.My diagnosis of AML is confirmed by the latest WHO criteria.I understand and agree to the study's requirements and am willing to participate.I had cancer before, but it was either early stage, treated and not requiring further therapy, or a specific type of skin or in situ cancer.My leukemia is sensitive to a specific treatment due to certain genetic changes.My heart condition limits my physical activity beyond basic tasks.I have a history of blood disorders such as myelofibrosis or chronic leukemia.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.I cannot stop taking medication that affects how my body processes drugs.I can stop taking certain fungal infection medicines or other strong medicines affecting my liver enzymes for 7 days or 5 half-lives before starting the trial.My white blood cell count is over 25,000, treatment to lower it is okay.I have HIV and understand the potential interaction with venetoclax treatment.I can care for myself but may not be able to do heavy physical work.I have been treated with specific drugs or therapies for my blood disorder.I cannot take medicine by mouth due to a digestive issue.My acute myeloid leukemia has spread to my brain or spinal cord.My kidney function is severely impaired.I do not have an uncontrolled infection needing treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Oral administration of ASTX727 and Venetoclax combination
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are being tested in this experiment?
"Unfortunately, this study is not admitting patients at the moment. The trial was initially posted on 2/9/2021 and was last updated on 10/5/2022. However, there are presently 1592 trials actively admitting patients with leukemia, myeloid, acute and 313 studies for Venetoclax actively looking for participants."
Answered by AI
Is this clinical trial accessible in different parts of the country?
"So far, this trial has enrolled 32 patients from locations including MD Anderson Cancer Center Site#101 in Houston, University of Calgary - Health Sciences Centre Site #502 in Calgary, and Yale University Site#109 in New Haven."
Answered by AI
Are there any available slots for patients who wish to enroll in this clinical trial?
"Unfortunately, this study is not enrolling patients at the moment. The listing was created on February 9th, 2021 and updated October 5th, 2022. There are currently 1592 trials actively recruiting participants with leukemia, myeloid, acute and 313 trials for Venetoclax admitting patients."
Answered by AI
What are some other notable examples of Venetoclax's medical applications?
"As of right now, 313 clinical trials are still ongoing and studying Venetoclax. 44 of these studies are in Phase 3. The majority of the trials for Venetoclax are located in Edmonton, Alberta; however, there are 8662 total locations running studies for this medication."
Answered by AI
To what end does Venetoclax usually lend itself?
"While often used as a treatment for refractory anemia, Venetoclax can also help patients with intermediate-1 ipss risk category, chronic lymphocytic leukemia (cll), and intermediate-2 ipss risk category."
Answered by AI
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