← Back to Search

Anti-tumor antibiotic

Venetoclax + HMA for Acute Myeloid Leukemia

Phase 2
Recruiting
Led By Jessica K Altman
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have the FLT3-ITD or D835 mutation based on MyeloMATCH Master Screening and Reassessment Protocol (MSRP)
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration/randomization are eligible for this trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Summary

This trial is comparing two different treatments for older and unfit patients with acute myeloid leukemia and FLT3 mutations. One treatment includes the drugs azacitidine and venetoclax, while the

Who is the study for?
This trial is for older adults or those unfit for intensive therapy, aged 60+ or younger with specific health considerations. Participants must have AML with FLT3 mutations, no prior treatment with hypomethylating agents or FLT3 inhibitors, and not be pregnant or breastfeeding. They should agree to use effective contraception.
What is being tested?
The study compares usual AML treatment (azacitidine + venetoclax) against a combination of azacitidine, venetoclax, and gilteritinib. It aims to see if adding gilteritinib increases the percentage of patients achieving deeper remission compared to the standard approach.
What are the potential side effects?
Potential side effects include nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk and bleeding problems; fatigue; liver issues; and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has a specific genetic change known as FLT3-ITD or D835.
Select...
I am HIV-positive, on treatment, and my viral load is undetectable.
Select...
My chronic hepatitis B virus load is undetectable with treatment.
Select...
I had hepatitis C but have been treated and cured, or I am currently being treated with an undetectable viral load.
Select...
I do not have any ongoing or untreated infections.
Select...
My diagnosis is AML, not including specific subtypes like APL with PML-RARA.
Select...
I have never been treated with hypomethylating agents or FLT3 inhibitors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of measured residual disease (MRD) negative complete remission (CR)
Secondary study objectives
Event-free survival
Incidence of adverse events
Overall survival

Trial Design

3Treatment groups
Experimental Treatment
Group I: Regimen 3 (azacitidine, venetoclax, gilteritinib)Experimental Treatment6 Interventions
INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28, and gilteritinib PO on days 8-21 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-14 and gilteritinib PO on days 8-21 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
Group II: Regimen 2 (azacitidine, venetoclax, gilteritinib)Experimental Treatment6 Interventions
INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax and gilteritinib PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-7 and gilteritinib PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
Group III: Regimen 1 (azacitidine, venetoclax)Experimental Treatment5 Interventions
INDUCTION: Patients receive azacitidine IV or SC on days 1-7 of each cycle and venetoclax PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Azacitidine
2012
Completed Phase 3
~1440
Biospecimen Collection
2004
Completed Phase 3
~2020
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Gilteritinib
2014
Completed Phase 2
~560
Venetoclax
2019
Completed Phase 3
~2200

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,853 Total Patients Enrolled
Jessica K AltmanPrincipal InvestigatorECOG-ACRIN Cancer Research Group
~98 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top