Gilteritinib-Azacitidine-Venetoclax Combination Therapy in Patients With Relapsed/Refractory Leukemia

Sponsor
Florian Kuchenbauer
Study ID
NCT07755202
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • gilteritinib-azacitidine-venetoclax — COMBINATION_PRODUCT
    administration of combination therapy gilteritinib-azacitidine-venetoclax on repeated 28-day cycles for a minimum of 2 cycles. Gilteritinib will be taken daily and azacitidine-venetoclax on days 1-7 of each cycle.

Study Details

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

Key Dates

First listed
Aug 10, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Oct 1, 2029
Completion
May 1, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All Participants
    administration of combination therapy gilteritinib-azacitidine-venetoclax on repeated 28-day cycles for a minimum of 2 cycles. Gilteritinib will be taken daily and azacitidine-venetoclax on days 1-7 of each cycle.

Primary Outcome Measure

Efficacy of triplet regimen on AML FLT3-wt participants [ Time Frame: From enrollment to the end of treatment at week 8 ]

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