AML - Acute Myeloid LeukemiaPhase 2SEQUENCENCT06696183
Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment
A Phase 2 study testing Gilteritinib (GILT), Venetoclax (VEN) and Azacitidine (AZA) in people with AML - Acute Myeloid Leukemia, run by Technische Universität Dresden at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML - Acute Myeloid Leukemia
- What is being tested?
- Gilteritinib (GILT), Venetoclax (VEN) and Azacitidine (AZA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 25 Apr 2025to Apr 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Technische Universität Dresden
Dresden, 01307
Prof. Dr. Christoph Röllig, MD, MSc, +49 351 458 4190, sequence@ukdd.de
About this study
Official title: 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
- Conditions
- AML - Acute Myeloid Leukemia
- Being tested
- Gilteritinib (GILT), Venetoclax (VEN), Azacitidine (AZA)
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gilteritinib (GILT)Drug
80 mg
Venetoclax (VEN)Drug
400 mg
Azacitidine (AZA)Drug
75 mg/m²
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | GILT d1-d28 VEN d1-d7 AZA d1-d7 Receives: Drug: Gilteritinib (GILT); Drug: Venetoclax (VEN); Drug: Azacitidine (AZA) |
| Cohort 2 | Experimental | GILT d8-d28 VEN d1-d7 AZA d1-d7 Receives: Drug: Gilteritinib (GILT); Drug: Venetoclax (VEN); Drug: Azacitidine (AZA) |
| Cohort 3 | Experimental | GILT d1-d28 VEN d1-d14 AZA d1-d7 Receives: Drug: Gilteritinib (GILT); Drug: Venetoclax (VEN); Drug: Azacitidine (AZA) |
| Cohort 4 | Experimental | GILT d8-d28 VEN d1-d14 AZA d1-d7 Receives: Drug: Gilteritinib (GILT); Drug: Venetoclax (VEN); Drug: Azacitidine (AZA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of dose delivered/dose planned
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start25 Apr 2025
- Primary completionApr 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML - Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696183
- Sponsor's protocol ID
- TUD-SEQUNC-081
- Acronym
- SEQUENCE
- Status last verified
- May 2025
- First submitted
- 7 Nov 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Gilteritinib in Combination With Venetoclax and Azacitidine for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and FLT3 Mutations Ineligible for Intensive Treatment
- ClinicalTrials.gov ID
- NCT06696183
- Acronym / sponsor ID
- SEQUENCE / TUD-SEQUNC-081
- Conditions
- AML - Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Gilteritinib (GILT), Drug: Venetoclax (VEN), Drug: Azacitidine (AZA)GILT d1-d28 VEN d1-d7 AZA d1-d7 |
| Cohort 2 | Experimental | Drug: Gilteritinib (GILT), Drug: Venetoclax (VEN), Drug: Azacitidine (AZA)GILT d8-d28 VEN d1-d7 AZA d1-d7 |
| Cohort 3 | Experimental | Drug: Gilteritinib (GILT), Drug: Venetoclax (VEN), Drug: Azacitidine (AZA)GILT d1-d28 VEN d1-d14 AZA d1-d7 |
| Cohort 4 | Experimental | Drug: Gilteritinib (GILT), Drug: Venetoclax (VEN), Drug: Azacitidine (AZA)GILT d8-d28 VEN d1-d14 AZA d1-d7 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gilteritinib (GILT)80 mg | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| Venetoclax (VEN)400 mg | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| Azacitidine (AZA)75 mg/m² | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Ratio of dose delivered/dose planned
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gilteritinib (GILT), Venetoclax (VEN) and Azacitidine (AZA) in people with AML - Acute Myeloid Leukemia, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. Christoph Röllig, MD, MSc (+49 351 458 4190, sequence@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of dose delivered/dose planned (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.