Health Trials

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

ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTechnische Universität Dresden

About this trial

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.

Eligibility criteria

Qualifiers

Written informed consent

t(8;21)/RUNX1-RUNX1T1 or

inv(16) or t(16;16)/CBFB-MYH11 or

FLT3-ITD or

Disqualifiers

Previous antineoplastic treatment for AML other than hydroxyurea and/or cytarabine for emergency use (100-200 mg/m² per day on maximal 3 days)

Previous treatment with anthracyclines

central nervous system involvement

Isolated extramedullary AML

Trial design

Treatments tested in this trial

  • MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO
  • MAGNOLIA-trial: Midostaurin associated with conventional chemotherapy (AraC+DNR)+GO
  • MAGNOLIA-trial: conventional chemotherapy (AraC+DNR)+GO
  • MAGMA-trial:GO associated with conventional chemotherapy (AraC+DNR)+Midostaurin
  • MAGMA-trial: conventional chemotherapy (AraC+DNR)+Midostaurin

Treatment groups

214 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Technische Universität Dresden

Lead sponsor

Novartis Pharmaceuticals

Collaborator

Pfizer

Collaborator

Source ClinicalTrials.gov