drugset
drugset / Trial / NCT04385290

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

NCT04385290 ↗

Phase 1/2 Recruiting 214 enrolled Technical University Dresden Novartis Pharmaceuticals · collabPfizer · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2020-09-04
Primary completion
2027-04
Completion
2028-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemtuzumab Ozogamicin Monoclonal antibody 3 mg/m2 Intravenous
Subject Midostaurin Small molecule 25 mg Oral
Subject Midostaurin Small molecule 50 mg Oral
Background Cytarabine Small molecule 200 mg/m2 Intravenous
Background Cytarabine Small molecule 1500 mg/m2 Intravenous
Background Cytarabine Small molecule 3000 mg/m2 Intravenous
Background Daunorubicin Small molecule 50 mg/m2 Intravenous
Background Daunorubicin Small molecule 60 mg/m2 Intravenous

Indications

acute myeloid leukemia