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DNA Methyltransferase Inhibitor
Navitoclax + Venetoclax + Decitabine for Acute Myeloid Leukemia
Phase 1
Recruiting
Led By Guido Marcucci
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing navitoclax, venetoclax, and decitabine to treat relapsed or refractory acute myeloid leukemia. The goal is to find the best dose of navitoclax with the least side effects.
Who is the study for?
This trial is for adults and adolescents (16-18 years old, weighing at least 45 kg) with acute myeloid leukemia that has not improved or returned after treatment with venetoclax. Participants must have a stable heart function, normal blood counts, liver and kidney functions within certain limits, no severe infections like HIV or hepatitis, and agree to use birth control.Check my eligibility
What is being tested?
The trial is testing the safety and optimal dosage of navitoclax in combination with venetoclax and decitabine in patients whose acute myeloid leukemia has relapsed or is refractory. These drugs aim to stop cancer cells from growing by killing them or preventing their division.See study design
What are the potential side effects?
Potential side effects may include but are not limited to nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, liver dysfunction, kidney issues, gastrointestinal symptoms like diarrhea or constipation.
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
Incidence of adverse events
Secondary outcome measures
Dose Limiting Toxicity (DLT)
Overall Survival (OS)
Overall response rate
+1 moreOther outcome measures
Change in percent blasts in bone marrow
Change in percent blasts in peripheral blood
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (navitoclax, venetoclax, decitabine)Experimental Treatment3 Interventions
Patients receive venetoclax PO QD and navitoclax PO QD on days 1-35, and decitabine IV over 1 hour on days 8-12 of cycle 1. Starting on cycle 2, patients receive venetoclax PO QD and navitoclax PO QD on days 1-28, and decitabine IV over 1 hour on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680
Venetoclax
2019
Completed Phase 3
~1990
Navitoclax
2012
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,624 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,969 Total Patients Enrolled
Guido MarcucciPrincipal InvestigatorCity of Hope Medical Center
7 Previous Clinical Trials
728 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with Gilbert's disease.You have a condition that makes it difficult for you to absorb medication through your digestive system.You have a currently active disease affecting your brain or spinal cord.You are currently experiencing diarrhea.You have a serious medical condition that is not being managed or controlled properly.You cannot participate if you have any other form of cancer, unless it is basal/squamous cell carcinoma, in situ breast cancer or in situ uterine cancer that has been successfully treated.If the doctor thinks that it is not safe for you to take part in the study because of certain medical conditions you have.You are able to swallow pills.If you have rapidly progressing leukemia, you can continue using hydroxyurea to control it until the first cycle of treatment begins.You are currently experiencing GVHD, a condition where donated tissue is attacking your body.You cannot have grapefruit, Seville oranges, or star fruit for 3 days before starting the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (navitoclax, venetoclax, decitabine)
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 does Navitoclax pose a danger to people?
"The available evidence for Navitoclax's safety and efficacy is limited, so it earned a score of 1 on our team's rating system."
Answered by AI
How many people have enrolled in this experiment?
"Affirmative. Based on the clinicaltrials.gov website, this research is presently recruiting subjects. The trial was introduced to the public on July 29th 2022 and its details were last updated on August 15th 2022. It aims to enroll 36 test subjects at two different hospitals or clinics."
Answered by AI
Is recruitment still ongoing for this research study?
"Yes, the clinicaltrials.gov listing indicates that this trial is currently enrolling members. It was initially posted on July 29th 2022 and has most recently been updated on August 15th 202 . 36 volunteers will be recruited from two medical facilities."
Answered by AI
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