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Epigenetic Modifier
Venetoclax Combination Therapy for Acute Myeloid Leukemia
Phase 1
Recruiting
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with AML must have measurable disease (≥M1 marrow) in the bone marrow
Renal and hepatic function- Patients must have adequate renal and hepatic functions as indicated by specific laboratory values
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 months
Awards & highlights
Study Summary
This trial is testing a new way to treat AML with drugs and chemo, to help patients have a better response.
Who is the study for?
This trial is for AML patients who've relapsed or didn't respond to initial treatments. They must have recovered from previous therapies, have no severe infections or GVHD if post-transplant, and meet specific organ function criteria. Pregnant women can't participate, and contraception is required for those of childbearing potential.Check my eligibility
What is being tested?
The study tests adding venetoclax to azacitidine and vorinostat before standard chemo in AML patients. The goal is to improve treatment response by combining these drugs with chemotherapy agents like cytarabine and fludarabine.See study design
What are the potential side effects?
Potential side effects include nausea, diarrhea, low blood cell counts leading to increased infection risk, fatigue, liver issues, and possible allergic reactions. Venetoclax may also interact with other drugs affecting its dosage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My AML is detectable in my bone marrow.
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My kidney and liver tests are within normal ranges.
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I am not taking any drugs that affect CYP3A4 enzyme activity.
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I am mostly able to carry out daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Venetoclax Dose-Limiting Toxicity
Secondary outcome measures
MRD
Response Rates
Trial Design
2Treatment groups
Experimental Treatment
Group I: AML without Down SyndromeExperimental Treatment6 Interventions
The subject receives 2 courses of therapy approximately 35 days each. Venetoclax: Days 1-14 Azacitidine and Vorinostat: Days 1-5 Filgrastim Days: 5 start and continue until post-nadir ANC > 500 cells/mm3 Fludarabine and Cytarabine Days 6 - 10 IT Cytarabine Day 0 or 1, optional between day 35 and 42
Group II: AML with Down SyndromeExperimental Treatment6 Interventions
The subject receives 2 courses of therapy approximately 35 days each. Venetoclax: Days 1-14 Azacitidine and Vorinostat: Days 1-5 Filgrastim Days: 5 start and continue until post-nadir ANC > 500 cells/mm3 Fludarabine and Cytarabine Days 6 - 10 IT Cytarabine Day 0 or 1, optional between day 35 and 42
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved
Azacitadine
2016
Completed Phase 3
~360
Cytarabine
FDA approved
Fludarabine
FDA approved
Vorinostat
FDA approved
Filgrastim
FDA approved
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,673 Total Patients Enrolled
Michael Burke, MDStudy ChairMedical College of Wisconsin
4 Previous Clinical Trials
855 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has returned after treatment or did not respond to initial treatments.My AML is detectable in my bone marrow.My kidney and liver tests are within normal ranges.I am not taking any drugs that affect CYP3A4 enzyme activity.I have AML caused by previous cancer treatments and it's either new or relapsed.I am mostly able to carry out daily activities.My leukemia has changed from ALL to AML and is not responding to treatment.I have recovered from side effects of my previous cancer treatments.I may have cancer spread to my brain or other areas, but I haven't had brain radiation during this treatment.I have an infection that hasn't improved with treatment, but I've been off pressors and had negative blood cultures for 48 hours.I do not have a genetic disorder like Fanconi anemia.I plan to receive other cancer treatments not listed in the study during the trial.
Research Study Groups:
This trial has the following groups:- Group 1: AML without Down Syndrome
- Group 2: AML with Down Syndrome
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 perilous can this therapy be for those undergoing it?
"Assessing the safety of this treatment on a scale from 1 to 3, our team at Power has determined that it is only suitable for Phase 1 trials. This means there is limited evidence available concerning efficacy and security protocols."
Answered by AI
Is there any way for me to participate in this medical experiment?
"Eligibility for this trial mandates that patients have a diagnosis of acute myeloid leukemia and are between one year old and 25 years old. The recruitment process seeks 40 participants in total."
Answered by AI
Is there currently any availability for participants in this trial?
"The trial is open for applications at present, with the initial posting on March 31st 2023 and a subsequent edit taking place April 28th. Patient recruitment information can be found via clinicaltrials.gov."
Answered by AI
How many participants is the research team looking to recruit for this trial?
"True, according to clinicaltrials.gov the trial posted on March 31st 2023 is recruiting participants. 40 individuals are required for this experiment which will be conducted at a single site and was most recently revised on April 28th 2023."
Answered by AI
Is the minimum age requirement for this trial below eighteen years old?
"This medical investigation has established an age range of 1 year to 25 years old for eligible participants. Separately, 451 trials are open for minors and 1190 studies are available to persons over 65."
Answered by AI
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