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RecruitingNCT06696183SEQUENCEUpdated May 29, 2025

Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment

A Phase 2 interventional study of Gilteritinib (GILT) and Venetoclax (VEN) in AML - Acute Myeloid Leukemia, sponsored by Technische Universität Dresden. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-29.

Sponsored by Technische Universität Dresden · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • AML - Acute Myeloid Leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 60 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Technische Universität Dresden is the lead sponsor of 237 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Cohort 1

    GILT d1-d28 VEN d1-d7 AZA d1-d7

    Drug: Gilteritinib (GILT) · Drug: Venetoclax (VEN) · Drug: Azacitidine (AZA)

  • Experimental
    Cohort 2

    GILT d8-d28 VEN d1-d7 AZA d1-d7

    Drug: Gilteritinib (GILT) · Drug: Venetoclax (VEN) · Drug: Azacitidine (AZA)

  • Experimental
    Cohort 3

    GILT d1-d28 VEN d1-d14 AZA d1-d7

    Drug: Gilteritinib (GILT) · Drug: Venetoclax (VEN) · Drug: Azacitidine (AZA)

  • Experimental
    Cohort 4

    GILT d8-d28 VEN d1-d14 AZA d1-d7

    Drug: Gilteritinib (GILT) · Drug: Venetoclax (VEN) · Drug: Azacitidine (AZA)

Interventions

  • DrugGilteritinib (GILT)

    80 mg

  • DrugVenetoclax (VEN)

    400 mg

  • DrugAzacitidine (AZA)

    75 mg/m²

06

What researchers measure

Primary outcomes

  1. Ratio of dose delivered/dose planned

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Technische Universität Dresden
    Dresden, 01307, Germany
    • Prof. Dr. Christoph Röllig, MD, MSc · Contact · sequence@ukdd.de · +49 351 458 4190
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06696183
Lead sponsor
Technische Universität Dresden
Responsible party
Sponsor
First posted
Nov 20, 2024
Start date
Apr 25, 2025
Primary completion
Apr 2029 (estimated)
Completion
Apr 2030 (estimated)
Last update
May 29, 2025

Study contacts

Prof. Dr. Christoph Röllig, MD, MSc
Contact
sequence@ukdd.de
+49 351 458 4190

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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