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DNA Methyltransferase Inhibitor
Azacitidine + Venetoclax + Pevonedistat for Acute Myeloid Leukemia
Phase 1 & 2
Waitlist Available
Led By Nicholas Short
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
MDS/CMML POST-HMA FAILURE COHORT ONLY: Diagnosis of MDS or CMML with intermediate-1, intermediate-2, or high-risk disease by the IPSS who have no responded, progressed, or relapsed after treatment with at least 4 cycles of azacitidine and/or decitabine
NEWLY DIAGNOSED MDS/CMML COHORT ONLY: Diagnosis of MDS or CMML with intermediate-2 or high-risk disease by the International Prognostic Scoring System (IPSS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat acute myeloid leukemia.
Who is the study for?
This trial is for adults with newly diagnosed acute myeloid leukemia who have not received certain previous treatments and are not suitable for intensive chemotherapy. They should be in a relatively good physical state (ECOG 0-2), able to practice effective contraception, and have adequate organ function. Those with severe infections, heart conditions, or other serious health issues unrelated to cancer are excluded.Check my eligibility
What is being tested?
The study is testing the combination of three drugs: Azacitidine, Venetoclax, and Pevonedistat. It aims to find the best dose of Venetoclax alongside the other two drugs and evaluate how well this trio works together against acute myeloid leukemia by stopping cancer cells from growing.See study design
What are the potential side effects?
Potential side effects may include nausea, vomiting, diarrhea, fatigue, risk of infection due to low blood cell counts, liver problems indicated by yellowing skin or eyes (jaundice), shortness of breath if lung problems occur. The severity can vary from mild discomforts to more serious complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have MDS or CMML and my treatment with azacitidine or decitabine did not work.
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I have been newly diagnosed with MDS or CMML and it is considered intermediate-2 or high-risk.
Select...
I am able to care for myself and perform daily activities.
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I have had chemotherapy or radiation for a different cancer.
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I have a history of Myelodysplastic Syndromes (MDS).
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I have a history of specific blood disorders and my cancer does not involve the BCR-ABL gene.
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I have MDS or CMML and my treatment with azacitidine or decitabine for at least 4 cycles did not work.
Select...
I am a male using effective contraception or practicing abstinence.
Select...
I am able to get out of my bed or chair and move around.
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I have a history of a specific blood disorder like PV, ET, or MF.
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My condition involves a genetic abnormality related to MDS, not including del9q.
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
CR + marrow CR (mCR) + partial remission (PR) + hematological improvement (HI) rate of the combination regimen (Phase II MDS/CMML post-hypomethylating agent failure cohort)
Complete response (CR)/complete response with incomplete bone marrow recovery (CRi) rate (Phase II acute myeloid leukemia cohort)
Complete response rate of the combination regimen (Phase II newly diagnosed myelodysplastic syndrome [MDS]/chronic myelomonocytic leukemia [CMML] cohort)
+1 moreSecondary outcome measures
Duration of response
Event-free survival (EFS)
Incidence of adverse events
+4 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Hypokalaemia
11%
Blood creatinine increased
11%
Neutrophil count decreased
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Dermatitis
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, azacitidine, pevonedistat)Experimental Treatment3 Interventions
Patients receive venetoclax PO QD on days 1-28, azacitidine IV or SC on days 1-7, and pevonedistat IV over 60 minutes on days 1, 3, and 5. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Pevonedistat
2021
Completed Phase 2
~290
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,468 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,331 Total Patients Enrolled
Nicholas ShortPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
146 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment except for specific exceptions in the last 14 days.I have MDS or CMML and my treatment with azacitidine or decitabine did not work.My blood disorder shows abnormal cell changes in at least half of certain blood cells, without specific genetic mutations.My cancer is only present outside the bone marrow.Your bilirubin levels should not be too high, except if you have a condition called Gilbert's syndrome, or if the high levels are related to your leukemia. If you have Gilbert's syndrome or high levels due to leukemia, you may still be able to participate if your direct bilirubin levels are within a certain range.I have a history of specific blood disorders and my cancer does not involve the BCR-ABL gene.I have newly diagnosed AML with a history of MDS, MPN, or exposure to chemotherapy or radiation for another cancer.I am HIV positive with a CD4 count over 350, undetectable viral load, on specific HIV meds, and no severe infections.I do not have a life-threatening illness with a life expectancy of less than 1 year.I have a severe lung condition like COPD, lung scarring, or fibrosis.I am willing and able to undergo strong chemotherapy for AML.I have been diagnosed with acute promyelocytic leukemia.I have been newly diagnosed with MDS or CMML and it is considered intermediate-2 or high-risk.I am able to care for myself and perform daily activities.I have had chemotherapy or radiation for a different cancer.I have MDS/CMML and have been treated with hypomethylating agents.I have a history of Myelodysplastic Syndromes (MDS).I have not had major surgery in the last 14 days.I haven't taken strong CYP3A4 inducers in the last 14 days.I do not plan to donate eggs during the study or for 4 months after the last dose.I am allergic to azacitidine, mannitol, pevonedistat, or similar drugs.I have severe liver problems or cirrhosis.I have MDS or CMML and my treatment with azacitidine or decitabine for at least 4 cycles did not work.I am a male using effective contraception or practicing abstinence.I am able to get out of my bed or chair and move around.I have a history of a specific blood disorder like PV, ET, or MF.I am currently pregnant, breastfeeding, or lactating.I will not donate sperm during the study or for 4 months after the last dose.I have a known heart or lung condition.I am a woman who is either postmenopausal, cannot have children, or I use two forms of birth control.My condition involves a genetic abnormality related to MDS, not including del9q.I do not have any severe or uncontrolled infections.I have been newly diagnosed with MDS or CMML and it is considered intermediate-2 or high-risk.I have been treated with venetoclax or pevonedistat for my MDS/CMML.I do not have a severe bleeding disorder unrelated to leukemia.I do not have any serious health or mental conditions that could stop me from completing the study.I do not have another cancer that could affect this treatment's safety or results.I haven't taken any experimental cancer drugs in the last 2 weeks.My cancer has spread to my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (venetoclax, azacitidine, pevonedistat)
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 total participants are allowed in this research project?
"Unfortunately, this specific clinical trial is not presently looking for patients. Although, it is worth noting that there are currently 4189 other clinical trials actively enrolling patients with leukemia and 358 studies involving Venetoclax that are actively recruiting participants."
Answered by AI
What are the main conditions that Venetoclax is utilized for?
"Venetoclax is most often used as part of induction chemotherapy, but it can also help patients with refractory anemias, leukemia, myelocytic, acute, multilineage dysplasia."
Answered by AI
What are some other areas of research in which Venetoclax has been used?
"There are 358 ongoing clinical trials studying Venetoclax, with 55 of them in Phase 3. Many Edmonton-based trials are running out of locations, however there are 11350 total study sites for Venetoclax across the world."
Answered by AI
Will this experiment be recruiting new participants soon?
"This study is not recruiting at the moment. It was originally posted on February 27th, 2019 and last updated on October 20th, 2022. However, there are other studies that may be of interest; 4189 trials related to leukemia (neutrophilic, chronic) and 358 for Venetoclax are currently looking for patients."
Answered by AI
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