Combining Gilteritinib with Venetoclax and Azacitidine for AML Patients with FLT3 Mutations
Sequential Gilteritinib in Combination With Venetoclax and Azacitidine for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and FLT3 Mutations Ineligible for Intensive Treatment
PHASE2 · Technische Universität Dresden · NCT06696183
This study is testing if adding Gilteritinib to the standard treatments of Venetoclax and Azacitidine can help newly diagnosed AML patients with FLT3 mutations who can't have intensive chemotherapy.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technische Universität Dresden (other) |
| Drugs / interventions | Gilteritinib, chemotherapy |
| Locations | 1 site (Dresden) |
| Trial ID | NCT06696183 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the optimal tolerable and effective dose of Gilteritinib when used alongside standard treatments, Venetoclax and Azacitidine, for patients diagnosed with Acute Myeloid Leukemia (AML) who have FLT3 mutations and are not eligible for intensive chemotherapy. The study focuses on newly diagnosed AML patients with a minimum bone marrow blast count of 20%. Participants will have received only one cycle of the approved combination of Venetoclax and Azacitidine prior to enrollment. The goal is to improve treatment outcomes for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates include newly diagnosed AML patients with FLT3 mutations who are ineligible for standard induction chemotherapy.
Not a fit: Patients with relapsed/refractory AML or those who have previously received treatment with Gilteritinib may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new effective treatment option for AML patients with FLT3 mutations who cannot undergo intensive chemotherapy.
How similar studies have performed: While this specific combination has not been extensively tested, similar approaches in targeting FLT3 mutations in AML have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dresden
- Technische Universität Dresden — Dresden, Germany (RECRUITING)
Study contacts
- Study coordinator: Prof. Dr. Christoph Röllig, MD, MSc
- Email: sequence@ukdd.de
- Phone: +49 351 458 4190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: AML - Acute Myeloid Leukemia