MidOStaurin + Gemtuzumab OzogAmIcin Combination in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514014-13-00

Acronym

TUD-MOSAIC-075

Enrollment

214

Registered

2024-11-08

Start date

2020-09-02

Completion date

Unknown

Last updated

2025-12-15

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

Conditions

female and male adult patients with acute myeloid leukemia

Brief summary

Primary endpoint dose escalation part (phase I, MODULE): Maximum tolerated dose (MTD) of midostaurin and GO in combination, Primary endpoint expansion part (phase II in CBF AML, MAGNOLIA): Event-free survival; event is being defined as either primary treatment failure or relapse or death, whichever occurs first, Primary endpoint expansion part (phase II in FLT3mut AML, MAGMA): Event-free survival; event is being defined as either primary treatment failure or relapse or death, whichever occurs first

Interventions

DRUGMYLOTARG 5 mg powder for concentrate for solution for infusion

DRUGRydapt 25 mg soft capsules

DRUGCYTARABINE

DRUGDAUNORUBICIN HYDROCHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary endpoint dose escalation part (phase I, MODULE): Maximum tolerated dose (MTD) of midostaurin and GO in combination, Primary endpoint expansion part (phase II in CBF AML, MAGNOLIA): Event-free survival; event is being defined as either primary treatment failure or relapse or death, whichever occurs first, Primary endpoint expansion part (phase II in FLT3mut AML, MAGMA): Event-free survival; event is being defined as either primary treatment failure or relapse or death, whichever occurs first	—

Measure

Time frame

—

Countries

Germany

Outcome results

None listed

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