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Hypomethylation Agent
Venetoclax + ASTX727 for Chronic Myelomonocytic Leukemia
Phase 2
Recruiting
Led By Rory M Shallis
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests whether a combo of meds can better reduce bone marrow cancer symptoms in certain types of leukemia.
Who is the study for?
Adults with chronic myelomonocytic leukemia or myelodysplastic/myeloproliferative neoplasm who haven't had specific previous treatments for these conditions. Participants must be able to swallow pills, have a certain level of heart and organ function, and not have uncontrolled illnesses. Pregnant women are excluded, and participants must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing if combining Venetoclax with ASTX727 (a mix of Decitabine and Cedazuridine) is more effective than ASTX727 alone in reducing symptoms of bone marrow cancer in patients with CMML or MDS/MPN with excess blasts.See study design
What are the potential side effects?
Potential side effects include issues related to blood cell production, digestive system disturbances, liver enzyme changes, kidney function impairment, potential infection risk increase due to immune suppression, fatigue, and possible allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response rate
Secondary outcome measures
Incidence of adverse events
Overall survival (OS)
Progression-free survival (PFS)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (ASTX727, venetoclax)Experimental Treatment4 Interventions
Patients receive ASTX727 PO QD for 5 consecutive days starting on day 3 of treatment cycle 1; followed by day 1 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD on days 1 through 14 of each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsies, and collection of blood and buccal samples throughout the study.
Group II: Arm II (ASTX727)Active Control4 Interventions
Patients receive ASTX727 PO QD for 5 consecutive days starting on day 3 of treatment cycle 1; followed by day 1 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who do not have response to treatment may cross over to Arm I. Patients also undergo bone marrow biopsies, and collection of blood and buccal samples throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Biospecimen Collection
2004
Completed Phase 2
~1700
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,309 Total Patients Enrolled
Rory M ShallisPrincipal InvestigatorYale University Cancer Center LAO
1 Previous Clinical Trials
94 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have another cancer that affects the safety or study of the treatment.My kidney function is within the safe range for the trial.I have brain or spinal issues not requiring immediate surgery.I am HIV-positive, on treatment, and my viral load has been undetectable for 6 months.I can take care of myself and perform daily activities.I do not have an active infection.My white blood cell count is below 10,000, possibly after taking hydroxyurea.My heart function is classified as class 2B or better according to NYHA.I am breastfeeding and taking venetoclax.I need urgent treatment for my condition, but not hydroxyurea.I have MDS/MPN with at least 5% marrow blasts and may use hydroxyurea until therapy starts.My hepatitis B virus is under control with treatment.I am allergic to medications similar to ASTX727 or venetoclax.I can understand and sign the consent form, or I have someone who can do it for me.I've had treatments for MDS/MPN, AML, or MDS excluding hydroxyurea but stopped ESA or thrombopoietic agents 4 weeks ago.I am 18 years old or older.I have another cancer, but it won't affect this treatment's safety or results.I had hepatitis C but have been treated and cured, or I am currently being treated with an undetectable viral load.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (ASTX727)
- Group 2: Arm I (ASTX727, venetoclax)
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.
Are individuals currently being recruited for this trial?
"Affirmative. According to the information published on clinicaltrials.gov, this medical trial is currently recruiting participants and was first posted on April 21st 2023. The latest update took place 4 days later on April 25th 2023. This trial requires 120 people from 1 different facility to take part in it."
Answered by AI
Does the administration of Arm I (ASTX727, venetoclax) pose any risks to human health?
"We rate the safety of Arm I (ASTX727, venetoclax) as a 2 on our 1-3 scale. This reflects that there is evidence in favour of its safety but no data yet confirming efficacy."
Answered by AI
How many participants has the clinical trial accepted thus far?
"Affirmative, the data on clinicaltrials.gov reveals that this medical trial is actively recruiting participants. It was first posted on April 21st 2023 and last updated on April 25th 2023. The research team needs to enrol 120 individuals from 1 site for the study."
Answered by AI
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