NCT06696183 Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment
| NCT ID | NCT06696183 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Technische Universität Dresden |
| Condition | AML - Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-25 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-04-25 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06696183 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying AML - Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06696183 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06696183 currently recruiting?
Yes, NCT06696183 is actively recruiting participants. Contact the research team at sequence@ukdd.de for enrollment information.
Where is the NCT06696183 trial being conducted?
This trial is being conducted at Dresden, Germany.
Who is sponsoring the NCT06696183 clinical trial?
NCT06696183 is sponsored by Technische Universität Dresden. The trial plans to enroll 60 participants.
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