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

Recruiting now · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT04385290

Run by

Technische Universität Dresden

People needed

214

Starts

2020-09-04

Expected to finish

2028-04-01

Last updated by the study team

2025-09-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent
• Newly diagnosed AML according to the criteria of the World Health Organisation plus the following molecular or cytogenetic specifications:
• Phase I Trial - MODULE:
• t(8;21)/RUNX1-RUNX1T1 or
• inv(16) or t(16;16)/CBFB-MYH11 or
• FLT3-ITD or
• FLT3-tyrosine kinase domain (FLT3-TKD)
• Phase II Trial - MAGNOLIA
• t(8;21)/RUNX1-RUNX1T1 or
• inv(16) or t(16;16)/CBFB-MYH11
• Phase II Trial - MAGMA
• FLT3-ITD or
• FLT3-TKD
• Absence of mutations in CBF genes (i.e. t(8;21)/RUNX1-RUNX1T1 or inv(16) or t(16;16)/CBFB-MYH11)
• Male and female patients aged
• 18 - ≤ 75 years in Phase I Trial - MODULE
• 18 - ≤ 70 years in Phase II Trials - MAGMA and MAGNOLIA
• Eastern Cooperative Oncology Group (ECOG) Score of 0-2
• Life expectancy > 14 days
• Adequate hepatic and renal function
• alanine aminotransferase / aspartate transaminase ≤ 2.5 x ULN
• Bilirubin < 2 x upper limits of normal
• Creatinine < 1.5 x upper limits of normal or Creatinine clearance > 40 ml/min
• White blood cell count < 30 × 10\^9/L. Note: Hydroxyurea and/or a dose of 100-200 mg/m\^2 cytarabine per day for up to 3 days (for emergency use for clinical stabilization) is permitted to meet this criterion.
• Exclusion Criteria (all study parts):

Where it is running

• Rems-Murr-Klinikum Winnenden — Winnenden, Germany (enrolling)
• Universitätsklinikum Essen — Essen, North Rhine-Westphalia, Germany (enrolling)
• Universitätsklinikum Aachen — Aachen, Germany (enrolling)
• Robert-Bosch-Krankenhaus — Stuttgart, Germany (enrolling)
• LMU Klinikum, Campus Großhadern — München, Bavaria, Germany (enrolling)
• Klinikum Chemnitz gGmbH — Chemnitz, Germany (enrolling)
• Universitätsklinikum Dresden — Dresden, Germany (enrolling)
• Johann Wolfgang Goethe-Universität — Frankfurt am Main, Germany (enrolling)
• Universitätsklinikum Halle — Halle, Germany (enrolling)
• Universitätsklinikum Heidelberg — Heidelberg, Germany (enrolling)
• Universitätsklinikum Jena — Jena, Germany (enrolling)
• Universitätsklinikum Schleswig-Holstein — Kiel, Germany (enrolling)
• Gemeinschaftsklinikum Mittelrhein gGmbH — Koblenz, Germany (enrolling)
• Universitätsklinikum Leipzig — Leipzig, Germany (enrolling)
• Klinikum Mannheim gGmbH — Mannheim, Germany (enrolling)
• Philipps-Universität Marburg Fachbereich Medizin — Marburg, Germany (enrolling)
• Rotkreuzklinikum München gGmbH — München, Germany (enrolling)
• Universitätsklinikum Münster — Münster, Germany (enrolling)
• Krankenhaus Barmherzige Brüder — Regensburg, Germany (enrolling)
• Universitätsklinikum Augsburg — Augsburg, Germany
• Klinikum Nürnberg-Nord — Nuremberg, Germany

Full record on ClinicalTrials.gov

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