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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507878-41-00
Acronym
TUD-SEQUNC-081
Enrollment
60
Registered
2024-08-26
Start date
2025-04-25
Completion date
Unknown
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia

Brief summary

Ratio of dose delivered/dose planned over the 12-cycle treatment period as evaluated at 12 months. This endpoint reflects both treatment efficacy (patients live longer event-free), and safety (less dose reductions, less omitted doses)

Detailed description

Ratio of dose delivered/dose planned over 2 cycles evaluated after 75 days, Complete hematologic remission/complete remission with partial hematologic recovery (CR/CRh), DOR, RFS, OS, CIR, Depth of response by MRD, Tolerability (Adverse events), Duration of cytopenias, transfusion dependence

Interventions

DRUGAZACITIDINE
DRUGVenclyxto 100 mg film-coated tablets

Sponsors

Technische Universitat Dresden
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Ratio of dose delivered/dose planned over the 12-cycle treatment period as evaluated at 12 months. This endpoint reflects both treatment efficacy (patients live longer event-free), and safety (less dose reductions, less omitted doses)

Secondary

MeasureTime frame
Ratio of dose delivered/dose planned over 2 cycles evaluated after 75 days, Complete hematologic remission/complete remission with partial hematologic recovery (CR/CRh), DOR, RFS, OS, CIR, Depth of response by MRD, Tolerability (Adverse events), Duration of cytopenias, transfusion dependence

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026