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Gilteritinib-Azacitidine-Venetoclax for Acute Myeloid Leukemia

(GAVE001 Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Florian Kuchenbauer
Must be taking: Azacitidine, Venetoclax
Disqualifiers: APL, BCR-ABL, Organ failure, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if gilteritinib-azacitidine-venetoclax combination drug therapy works to treat adults with FLT3-wt acute myeloid leukemia (AML). It will also learn about the safety and efficacy of this treatment. The main question this clinical trial aims to answer are:

* Will adding gilteritinib to standard-of-care therapy azacitidine-venetoclax show be more effective in treating AML FLT3-wt patients who have previously been treated with azacitidine and/or venetoclax for their disease and have had their cancer come back (relapsed) or have stopped responding to treatment (refractory)?

All participants in this trial will receive the combination therapy. Participants will be on repeated 28-day cycles, for a minimum of 2 cycles, while on the study

Participants will:

* Take the gilteritinib once daily, every day

* Take azacitidine and venetoclax on days 1-7 of each cycle

* Keep a daily dose diary of the days and times they have taken their treatments

* Visit the clinic every 4 weeks for checkups and tests

Are You a Good Fit for This Trial?

This trial is for adults (18+) with acute myeloid leukemia (AML) that has come back or stopped responding after treatment with azacitidine and venetoclax, who do not have certain gene mutations (FLT3-ITD/TKD), are in good enough health to participate, and are not pregnant or breastfeeding.

Inclusion Criteria

Participant willing to provide informed consent and comply with trial procedures
I am willing and able to use approved birth control before, during, and after the trial.
For participants of child-bearing potential (menstruation within <2 years), negative serum pregnancy test within 14 days prior to enrollment
See 7 more

Exclusion Criteria

My liver function tests are higher than normal limits.
I have not had any active cancer needing treatment in the past 2 years, except for certain cured or low-risk cancers.
Currently eligible for intensive chemotherapy treatment per Investigator opinion
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gilteritinib-azacitidine-venetoclax combination therapy in repeated 28-day cycles, for a minimum of 2 cycles

8 weeks
Clinic visits every 4 weeks for checkups and tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for event-free survival, relapse-free survival, and overall survival

36 months

What Are the Treatments Tested in This Trial?

Interventions

  • Azacitidine
  • Gilteritinib
  • Venetoclax

Trial Overview

The study tests a combination of three drugs—gilteritinib, azacitidine, and venetoclax—in people with relapsed/refractory AML. All participants receive the same treatment in repeating monthly cycles to see if adding gilteritinib improves outcomes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: All ParticipantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Florian Kuchenbauer

Lead Sponsor

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