Clinical trial · Interventional
Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment
Sequential Gilteritinib in Combination With Venetoclax and Azacitidine for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and FLT3 Mutations Ineligible for Intensive Treatment
NCT06696183CI-TRIAL-00090291SEQUENCErecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML - Acute Myeloid Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine (AZA) | Drug | Azacitidine | ALIAS |
| Gilteritinib (GILT) | Drug | Gilteritinib | ALIAS |
| Venetoclax (VEN) | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- GILT d1-d28 VEN d1-d7 AZA d1-d7
- interventionNames
- Drug: Gilteritinib (GILT)
- Drug: Venetoclax (VEN)
- Drug: Azacitidine (AZA)
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- GILT d8-d28 VEN d1-d7 AZA d1-d7
- interventionNames
- Drug: Gilteritinib (GILT)
- Drug: Venetoclax (VEN)
- Drug: Azacitidine (AZA)
- type
- EXPERIMENTAL
- label
- Cohort 3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.