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BCL-2 Inhibitor
Venetoclax + Chemotherapy for Acute Myeloid Leukemia
Phase 2
Recruiting
Led By Jeffrey E. Rubnitz, MD, PhD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study enrollment to disease resistance, relapse, development of a second malignancy, or death due to any cause (up to 3 years after the last enrollment).
Awards & highlights
Study Summary
This trial tests if adding venetoclax to chemo can help kids with AML, by measuring if it's safe and how well it works.
Who is the study for?
This trial is for pediatric patients aged over 28 days and under 22 years with newly diagnosed acute myeloid leukemia (AML), who haven't had prior treatment except possibly one dose of intrathecal therapy or specific low-dose chemotherapy. Participants must be able to tolerate the protocol therapy, not have certain infections or diseases that could affect safety or results, and agree to use effective contraception if applicable.Check my eligibility
What is being tested?
The study tests whether adding Venetoclax to standard chemotherapy is tolerable and effective in children with AML. It aims to see if this combination can reduce disease traces after one treatment course and improve rates of complete remission, event-free survival, and overall survival.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to lowered blood counts; plus any specific reactions related to Venetoclax which may involve gastrointestinal symptoms or liver function changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from protocol enrollment until death (up to 3 years after the last enrollment).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from protocol enrollment until death (up to 3 years after the last enrollment).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of death or unacceptable adverse event
Minimal residual disease (MRD)-negativity rate
Secondary outcome measures
Event-free survival
Overall survival
Trial Design
3Treatment groups
Experimental Treatment
Group I: Low RiskExperimental Treatment8 Interventions
All eligible patients receive intervention according to the Detailed Description section with the following:
Venetoclax, Cytabrine, Danunorubicin Hydrochloride, Gemtuzumab Ozogamicin, Etoposide, Mitoxantrone Hydrochloride, Gilteritinib
Group II: Intermediate RiskExperimental Treatment9 Interventions
All eligible patients receive intervention according to the Detailed Description section with the following:
Venetoclax, Cytabrine, Danunorubicin Hydrochloride, Fludarabine Phosphate, Gemtuzumab Ozogamicin, Etoposide, Idarubin Hydrochloride, Mitoxantrone Hydrochloride, Gilteritinib
Group III: High RiskExperimental Treatment9 Interventions
All eligible patients receive intervention according to the Detailed Description section with the following:
Venetoclax, Azacitidine, Cytabrine, Danunorubicin Hydrochloride, Fludarabine Phosphate, Gemtuzumab Ozogamicin, Etoposide, Idarubin Hydrochloride, Gilteritinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Idarubicin Hydrochloride
2013
Completed Phase 1
~50
Etoposide
2010
Completed Phase 3
~2440
Gemtuzumab Ozogamicin
2006
Completed Phase 4
~440
Gilteritinib
2014
Completed Phase 2
~560
Mitoxantrone Hydrochloride
2016
Completed Phase 3
~650
Azacitidine
2012
Completed Phase 3
~1440
Cytarabine
2016
Completed Phase 3
~3310
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5070
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,543 Total Patients Enrolled
AbbVieIndustry Sponsor
958 Previous Clinical Trials
502,320 Total Patients Enrolled
Jeffrey E. Rubnitz, MD, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital
5 Previous Clinical Trials
338 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use effective birth control during and for 6 months after the study.I am older than 28 days and younger than 22 years.I've only had one dose of spinal therapy and short-term low-dose treatment for my cancer.I am a woman who can have children and have a recent negative pregnancy test.I haven't taken strong medications like rifampin in the last 3 days.I do not have any severe infections or diseases that could affect my safety or participation in the study.I have been treated with anthracycline or anthracenedione before.I haven't taken strong medications like ketoconazole within the last 3 days.I have been diagnosed with a specific type of blood cancer according to WHO standards.I do not have any specific blood disorders or bone marrow failure syndromes.
Research Study Groups:
This trial has the following groups:- Group 1: Low Risk
- Group 2: Intermediate Risk
- Group 3: High Risk
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 there still opportunities to get involved in this research endeavor?
"According to the information present on clinicaltrials.gov, this particular medical study is not accepting participants at this time. Initially posted in August of 2023 and last updated in July of the same year, individuals can no longer submit their candidacy for this trial; however, 1553 other investigations are currently looking for volunteers."
Answered by AI
What implications does Low Risk pose to the wellbeing of individuals?
"With the available safety data, our team at Power has rated Low Risk's security a 2. This is due to this being a Phase 2 trial, and hence there is limited evidence of efficacy but some information regarding its safety."
Answered by AI
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