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

May 27, 2025 updated by: Technische Universität Dresden

Sequential Gilteritinib in Combination With Venetoclax and Azacitidine for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and FLT3 Mutations Ineligible for Intensive Treatment

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Prof. Dr. Christoph Röllig, MD, MSc
  • Phone Number: +49 351 458 4190
  • Email: sequence@ukdd.de

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • Technische Universität Dresden
        • Contact:
          • Prof. Dr. Christoph Röllig, MD, MSc
          • Phone Number: +49 351 458 4190
          • Email: sequence@ukdd.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
GILT d1-d28 VEN d1-d7 AZA d1-d7
Drug: Gilteritinib (GILT)
80 mg
Drug: Venetoclax (VEN)
400 mg
Drug: Azacitidine (AZA)
75 mg/m²
Experimental: Cohort 2
GILT d8-d28 VEN d1-d7 AZA d1-d7
Drug: Gilteritinib (GILT)
80 mg
Drug: Venetoclax (VEN)
400 mg
Drug: Azacitidine (AZA)
75 mg/m²
Experimental: Cohort 3
GILT d1-d28 VEN d1-d14 AZA d1-d7
Drug: Gilteritinib (GILT)
80 mg
Drug: Venetoclax (VEN)
400 mg
Drug: Azacitidine (AZA)
75 mg/m²
Experimental: Cohort 4
GILT d8-d28 VEN d1-d14 AZA d1-d7
Drug: Gilteritinib (GILT)
80 mg
Drug: Venetoclax (VEN)
400 mg
Drug: Azacitidine (AZA)
75 mg/m²

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ratio of dose delivered/dose planned
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2025

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUD-SEQUNC-081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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