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Anti-metabolites
Azacitidine/Decitabine + Venetoclax for Acute Myeloid Leukemia
Phase 2
Recruiting
Led By Brian A Jonas
Research Sponsored by Brian Jonas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of AML by World Health Organization (WHO) 2016 criteria (Arber 2016)
Treatment naïve and eligible for venetoclax plus HMA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before or has come back.
Who is the study for?
Adults diagnosed with acute myeloid leukemia (AML) who have not been treated for AML before or whose AML has returned. They must have previously failed treatment with hypomethylating agents for a related blood disorder and be able to take oral medication. Women of childbearing age must test negative for pregnancy and agree to use contraception, as should men with partners of childbearing potential.Check my eligibility
What is being tested?
The trial is testing the combination of chemotherapy drugs azacitidine or decitabine with venetoclax in patients with AML that's either new or has come back after previous treatments. The goal is to see how well these drugs work together in stopping cancer cell growth by killing them, halting division, or preventing spread.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, diarrhea, low blood counts leading to increased infection risk and bleeding problems, fatigue, liver issues indicated by abnormal tests results, kidney function changes requiring monitoring and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis is AML, confirmed by the latest WHO criteria.
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I have not received any treatment and am eligible for venetoclax plus HMA therapy.
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My previous treatment with HMA for a blood disorder did not work.
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I can swallow and keep down pills.
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I have been treated with decitabine or azacitidine for a blood disorder before.
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I am 18 years old or older.
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I can take care of myself but might not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate
Secondary outcome measures
Duration of CR/CRi (DoR)
Event-free survival
Incidence of adverse events
+5 moreSide 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 (azacitidine, decitabine, venetoclax)Experimental Treatment3 Interventions
Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7 (for patients with prior decitabine use), or decitabine IV on days 1-5 (for patients with prior azacitidine), and venetoclax PO daily on days 1-28. 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
Azacitidine
2012
Completed Phase 3
~1440
Decitabine
2004
Completed Phase 3
~1680
Find a Location
Who is running the clinical trial?
Brian JonasLead Sponsor
4 Previous Clinical Trials
70 Total Patients Enrolled
AbbVieIndustry Sponsor
958 Previous Clinical Trials
502,370 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,834 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with acute promyelocytic leukemia.My diagnosis is AML, confirmed by the latest WHO criteria.I am not using, and do not plan to use, any experimental drugs within 14 days before starting venetoclax.I had a bone marrow transplant for a blood disorder more than 3 months ago.I haven't taken strong or moderate CYP3A inducers in the last week.I have not received any treatment and am eligible for venetoclax plus HMA therapy.I have been diagnosed with HIV or active hepatitis A, B, or C.My acute myeloid leukemia has spread to my brain or spinal cord.I am currently being treated for a serious infection.My previous treatment with HMA for a blood disorder did not work.I can swallow and keep down pills.I have been treated with decitabine or azacitidine for a blood disorder before.I am 18 years old or older.I agree to use effective birth control during the study.I am a woman who can have children and have a negative pregnancy test before starting the study drug.I haven't had cancer treatments in the last 14 days or within 5 half-lives before starting venetoclax.I can take care of myself but might not be able to do active work.I cannot take medicine by mouth due to a digestive issue.My heart condition limits my physical activity significantly.I have had cancer before, but it was treated with the goal of curing it.I have been treated with venetoclax before.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (azacitidine, decitabine, 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.
To what degree is Venetoclax considered safe for human consumption?
"Our team evaluated the safety of Venetoclax to be a 2 on their rating scale, as there is only limited evidence supporting its protection and no proof yet confirming efficacy."
Answered by AI
What conditions is Venetoclax commonly employed to address?
"Venetoclax is often deployed as part of a chemotherapy protocol. Moreover, this drug can be applied to multiple other medical scenarios such as ipss risk category intermediate-2, refractory anemias, leukemia, myelocytic and acute forms."
Answered by AI
Are there any further experiments conducted on Venetoclax that are available to analyze?
"Currently, there are 413 active trials for Venetoclax with 67 in the final phase. Toronto is one of 11982 locations facilitating these medical studies, though many other cities across the globe are hosting them as well."
Answered by AI
Has enrollment begun for this trial yet?
"Per the information found on clinicaltrials.gov, this medical trial is actively recruiting participants. It was initially posted February 9th 2022 and saw its most recent update occur on March 11th of the same year."
Answered by AI
How many individuals are currently being enrolled in this clinical research?
"Affirmative. The online data hosted on clinicaltrials.gov affirms that this research project, which was first made available to the public on February 9th 2022, is still recruiting participants. Approximately 20 individuals need to be enrolled from 3 different medical centers."
Answered by AI
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