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Anti-metabolites
Azacitidine + Venetoclax + Gilteritinib for Leukemia
Phase 1 & 2
Waitlist Available
Led By Nicholas Short
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For all cohorts, patients with either FLT3-internal tandem duplication (FLT3-ITD) or FLT3 D835 mutations will be eligible
Phase II cohort A: Adults >= 18 years with newly diagnosed FLT3-mutated AML
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of gilteritinib in combination with azacitidine and venetoclax to treat patients with FLT3-mutation positive acute myeloid leukemia, chronic myelomonocytic leukemia, or high-risk myelodysplastic syndrome/myeloproliferative neoplasm.
Who is the study for?
Adults over 18 with FLT3-mutated acute myeloid leukemia, chronic myelomonocytic leukemia, or high-risk myelodysplastic syndrome/myeloproliferative neoplasm that's recurrent or refractory. Participants need a performance status of <=3 on the ECOG scale and adequate liver and kidney function. Exclusions include long QT syndrome, active central nervous system leukemia, HIV/hepatitis B/C infection, pregnancy/breastfeeding women, and those unwilling to use contraception.Check my eligibility
What is being tested?
The trial is testing how well gilteritinib works with azacitidine and venetoclax in treating certain blood cancers with FLT3 mutation. It aims to find the best dose of gilteritinib for effectiveness when combined with these chemotherapy drugs compared to using azacitidine and venetoclax alone.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, fatigue, nausea/vomiting, diarrhea/constipation, risk of infections due to low blood cell counts (neutropenia), bleeding issues (thrombocytopenia), liver problems indicated by elevated enzymes or bilirubin levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia has FLT3 mutations.
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I am an adult with newly diagnosed AML that has a FLT3 mutation.
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I can take care of myself but can't do heavy physical work.
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I can swallow normally.
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I am an adult with a specific type of leukemia or myelodysplastic syndrome that is considered high-risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum-tolerated dose (MTD) of gilteritinib (Phase I)
Overall response rate (OR) (Phase II)
Secondary outcome measures
Complete response rate
Incidence of adverse events
Minimal residual disease negativity
+3 moreOther outcome measures
Evaluation of leukemia stem cell populations
Impact of FLT3 allelic ratio
Impact of genomic alterations
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (azacitidine, venetoclax, gilteritinib)Experimental Treatment3 Interventions
Patients receive azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 and on days 1-21 of subsequent cycles, and gilteritinib PO QD on days 1-28. Treatment of azacytidine and venetoclax repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Cycles of gilteritinib 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
Azacitidine
FDA approved
Gilteritinib
FDA approved
Venetoclax
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,747 Total Patients Enrolled
Nicholas ShortPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
131 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.I can have had any number of previous treatments.My leukemia has spread to my brain or spinal cord.My leukemia has FLT3 mutations.I am an adult with newly diagnosed AML that has a FLT3 mutation.I can take care of myself but can't do heavy physical work.I have an ongoing serious infection that isn't getting better with antibiotics.I have AML and haven't received treatment for it, but may have had treatment for a blood disorder.I am willing and able to undergo intensive chemotherapy.I have not taken medications like carbamazepine or St. John's wort in the last 3 days.I haven't taken experimental cancer drugs in the last week, or I've recovered from their side effects.I am an adult with a specific type of blood cancer that has come back or didn’t respond to treatment.I am not pregnant, willing to use birth control, and not breastfeeding if female. I agree to use birth control if male.My heart's electrical activity is normal or corrected to be normal.My total bilirubin levels are within the normal range, unless it's due to specific conditions.My treatment history does not limit my participation.I have hepatitis B or C but my viral load is undetectable.I do not have severe heart failure.I can swallow normally.I am an adult with a specific type of leukemia or myelodysplastic syndrome that is considered high-risk.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (azacitidine, venetoclax, gilteritinib)
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.
Are there any other similar experiments that have been done with Azacitidine?
"Azacitidine is being trialled in 359 separate clinical studies at the moment, 58 of which are in the third stage. The majority of these trials are based in Toronto, Canada, but there are 11956 total locations running these tests."
Answered by AI
How is Azacitidine most commonly used?
"Azacitidine is often used to treat blood disorders. Additionally, it has shown efficacy in treating induction chemotherapy, refractory anemias, and acute myelocytic leukemia."
Answered by AI
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