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Nucleoside Metabolic Inhibitor
Triple-Drug Therapy for Acute Myeloid Leukemia
Phase 1 & 2
Recruiting
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 49 months
Awards & highlights
Study Summary
This trial is testing a new treatment of gilteritinib, venetoclax & azacitidine for people with acute myeloid leukemia (AML) who cannot have chemotherapy due to old age or other conditions.
Who is the study for?
This trial is for adults with newly diagnosed Acute Myeloid Leukemia (AML) who have a specific FLT3 gene change and can't have standard chemotherapy due to age or other health issues. They must be able to take oral medication, not be pregnant or breastfeeding, agree to use contraception, and not participate in another study.Check my eligibility
What is being tested?
The trial tests a combination of Gilteritinib, Venetoclax, and Azacitidine in patients with AML who have the FLT3 mutation. It aims to find suitable doses and assess how these drugs work together in the body over two phases involving different dosages on a 28-day cycle.See study design
What are the potential side effects?
Potential side effects may include typical reactions from cancer treatments such as nausea, fatigue, liver problems, blood cell count changes leading to increased infection risk or bleeding complications. Specific side effects will depend on individual responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 49 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 49 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants at each grade of the Eastern Cooperative Oncology Group (ECOG) performance status scores
Number of Participants with Adverse Events (AEs)
Number of Participants with Dose Limiting Toxicities (DLTs)
+8 moreSecondary outcome measures
Duration of Event free survival (EFS)
Duration of Overall Survival (OS)
Duration of Remission (DOR)
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose Ranging Cohort (Phase 1)Experimental Treatment3 Interventions
Participants will receive daily dose of gilteritinib and venetoclax for 28 days, and azacitidine for 7 days in each 28-day cycle.
Group II: Dose Expansion Cohort (Phase 2)Experimental Treatment3 Interventions
Participants will receive daily dose of gilteritinib, venetoclax, and azacitidine at an optimized dose established from dose ranging cohort (Phase 1)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gilteritinib
2014
Completed Phase 2
~560
Venetoclax
2019
Completed Phase 3
~1990
Azacitidine
2012
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
121,016 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,777 Previous Clinical Trials
8,063,670 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree not to breastfeed during and for 60 days after the study.I need to take medication that strongly affects liver enzymes or drug transporters during the study.I have serious heart condition limitations.I have not had any cancer except for certain skin cancers or treated early-stage cancers in the last 2 years.I have hepatitis C antibodies but no detectable virus in my blood.I have not had major surgery in the last 4 weeks.I have not consumed grapefruit, Seville oranges, or starfruit in the last 3 days.I have active hepatitis B, C, or another liver condition.My cancer has an FLT3 mutation, but not FLT3-ITD, D835, or I836.I had hepatitis C but have been treated and cured, or I am currently being treated with an undetectable viral load.I have been diagnosed with Acute Myeloid Leukemia for the first time.I can take pills and am willing to swallow tablets/capsules for the study.I've been tested for hepatitis B: core antibody positive, surface antigen negative, and no detectable virus.I have a history of specific blood disorders or leukemia.My organs and bone marrow are functioning well according to recent tests.My chronic hepatitis B virus infection is undetectable with treatment.I am a man who will use birth control during and for 4 months after the study.I need specific antifungal medication but can only use posaconazole in the first cycle.My blood or bone marrow has a FLT3 mutation.I have HIV but it has been undetectable for 6 months due to effective treatment.I will not donate eggs during and for 6 months after the study.I am a male and agree not to donate sperm during and for 120 days after the study.I will not have unprotected sex if my partner is pregnant or breastfeeding.I haven't had certain cancer treatments in the last 14 days or am recovered from their side effects.I am not pregnant and either cannot become pregnant or agree to use birth control during and after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion Cohort (Phase 2)
- Group 2: Dose Ranging Cohort (Phase 1)
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 places available in this clinical trial for people who want to participate?
"The most recent information available on clinicaltrials.gov suggests that this study is actively recruiting participants. This trial was first posted on November 2nd, 2020 and updated as recently as November 10th, 2020."
Answered by AI
What are the goals that researchers hope to achieve with this trial?
"According to the study sponsor, Astellas Pharma Global Development, Inc., the primary outcome being measured in this trial over a period of up to 49 months is percentage of participants who achieve complete remission (CR). Other secondary outcomes being measured include plasma concentration levels of ASP2215 pre-dose and at maximum observed concentration (Cmax), as well as the percentage of participants who achieve either complete remission or partial hematological recovery (CR/CRh) at any post-baseline visit."
Answered by AI
How many people are being given this opportunity to try the new treatment?
"This is accurate. As specified on clinicaltrials.gov, this study was recently posted (11/2/2022) and is actively recruiting patients for a total of 70 across 1 location."
Answered by AI
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