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Nucleoside metabolic inhibitor
Venetoclax + ASTX727 for High-Risk MDS/CMML
Phase 1 & 2
Recruiting
Led By Guillermo Garcia-Manero
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
Age >= 18 years of age
Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of a combination of venetoclax, cedazuridine, and decitabine in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia who have not received prior treatment.
Who is the study for?
Adults with untreated high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia, who have normal liver and kidney function tests, can join. They must not be pregnant, agree to contraception during the trial and for 3 months after, and cannot have had prior BCL2 inhibitor therapy or certain infections.Check my eligibility
What is being tested?
The trial is testing the safety and optimal dosage of venetoclax in combination with ASTX727 (cedazuridine plus decitabine) on patients. It aims to understand how these drugs work together to stop cancer cell growth by killing them or preventing their spread.See study design
What are the potential side effects?
Potential side effects may include typical chemotherapy reactions like fatigue, nausea, low blood counts leading to increased infection risk, liver issues reflected in altered blood tests, and possibly others depending on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am a male and will use birth control during and for 3 months after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of all reported adverse events (Phase I)
Overall response rate (ORR) (Phase II)
Secondary outcome measures
Disease-free survival
Duration of response
Event-free survival
+11 moreOther outcome measures
Biomarker analysis
Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Dermatitis
11%
Hypokalaemia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (venetoclax, ASTX727)Experimental Treatment2 Interventions
Patients receive venetoclax orally PO QD on days 1-14. Patients also receive ASTX727 PO QD on days 1-5. 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
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,091 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,344 Total Patients Enrolled
Astex Pharmaceuticals, Inc.Industry Sponsor
95 Previous Clinical Trials
7,909 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously received BCL2 inhibitor therapy.I have not taken strong or moderate CYP3A inducers in the last 7 days.I am pregnant.My heart condition limits my physical activity beyond basic tasks.I have hepatitis B or C but my viral load is undetectable.I have a chronic illness or allergy that may affect my participation in the study.I have had cancer before, but it was either skin cancer, treated cervical or breast cancer in situ, or any cancer treated with curative intent over 2 years ago.I have a high-risk blood disorder with specific risk scores and may have had treatment to lower my white cell count.I am currently fighting a serious infection that needs treatment.I have not had a live vaccine in the last 4 weeks.I cannot take medicine by mouth due to a digestive condition.I am 18 years old or older.My MDS is classified as low or intermediate-1 risk.I am a male and will use birth control during and for 3 months after the study.I am not able to have children, or if I can, I've tested negative for pregnancy and agree to use birth control during the study.I have HIV and understand there might be interactions with my treatment.My white blood cell count is above 25 x 10^9/L.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (venetoclax, ASTX727)
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.
What other research has been done on Venetoclax?
"As of now, there are 313 clinical trials investigating Venetoclax with 44 being in Phase 3. Many of these studies are based out of Toronto, Ontario; however, 8662 locations worldwide are conducting research on Venetoclax."
Answered by AI
Could you inform me how many individuals are currently enrolled in this clinical trial?
"Yes, this is an active recruitment according to the latest information available on clinicaltrials.gov. The trial was posted on 1/19/2021 and was last updated 8/22/2022. They are looking for 52 participants at 1 site."
Answered by AI
What are the main health conditions that Venetoclax is designed to target?
"Venetoclax is frequently used to treat refractory anemia, but it can also help manage ipss risk category intermediate-1 and chronic lymphocytic leukemia (cll)."
Answered by AI
Are people with the required medical condition still being accepted into this trial?
"That is accurate. According to clinicaltrials.gov, this study was first posted on January 19th, 2021 and is currently looking for 52 patients from 1 location."
Answered by AI
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