Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gilteritinib (GILT), Venetoclax (VEN), Azacitidine (AZA).
- Who it may be relevant to
- Registry conditions: AML - Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sequential Gilteritinib in Combination With Venetoclax and Azacitidine for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and FLT3 Mutations Ineligible for Intensive Treatment
Overview
Explore the best tolerable and efficacious dose of Gilteritinib when combined with standard treatment with Venetoclax and Azacitidine in AML patients with FLT3 mutations which are ineligible for intensive chemotherapy
Interventions
- Drug Gilteritinib (GILT)
80 mg - Drug Venetoclax (VEN)
400 mg - Drug Azacitidine (AZA)
75 mg/m²
Primary outcome measures
- Ratio of dose delivered/dose planned [Time frame: 12 months]
Eligibility criteria
Main Inclusion Criteria:
- Newly diagnosed AML (according to WHO 2022 or ICC 2022 criteria) with a minimum BM blast count of >=20%, excluding APL
- FLT3 mutation at initial diagnosis
- Ineligibility of standard induction chemotherapy
- Pre-treatment with approved combination of Venetoclax + Azacitidine (one cycle only)
Main Exclusion Criteria:
- R/R AML
- Previous treatment for AML (except HU and/or one cycle VEN+AZA according to SOC)
- Previous treatment with Gilteritinib
- Known active CNS involvement
- QTcF >450 ms or long QT Syndrome at screening
- Treatment with concomitant strong CYP3A inducers or St. John's wort
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Technische Universität Dresden — Dresden
Identifiers
NCT: NCT06696183 · TUD-SEQUNC-081