Clinical Trial

Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)

Study acronym: MOSAIC
Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
This phase I/II clinical trial evaluates the safety and efficacy of the combined administration of midostaurin and gemtuzumab ozogamicin in the frame of first-line standard chemotherapy in newly diagnosed acute myeloid leukemia (AML) patients displaying a cytogenetic aberration or fusion transcript in the core-binding factor (CBF) genes or FMS-like tyrosine Kinase 3 (FLT3) mutation.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2020-05-08; most recent amendment 2025-09-02.
Status change: Active, Not Recruiting → Recruiting 2022-11-28
Status change: Recruiting → Active, Not Recruiting 2021-08-31
Status change: Not Yet Recruiting → Recruiting 2020-09-28
Trial Details
NCT Number NCT04385290
Lead Sponsor Technische Universität Dresden
Collaborators: Novartis Pharmaceuticals, Pfizer
Conditions Acute Myeloid Leukemia
Enrollment 214 participants
Start Date 2020-09-04
Primary Completion 2027-04 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2025-09-08