Actively Recruiting
Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)
Led by Technische Universität Dresden · Updated on 2025-09-08
214
Participants Needed
21
Research Sites
395 weeks
Total Duration
On this page
Sponsors
T
Technische Universität Dresden
Lead Sponsor
N
Novartis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Newly diagnosed AML with one of the following: t(8;21)/RUNX1-RUNX1T1, inv(16) or t(16;16)/CBFB-MYH11, FLT3-ITD, or FLT3-TKD mutations
- Age 18 to 75 years for Phase I trial (MODULE)
- Age 18 to 70 years for Phase II trials (MAGNOLIA and MAGMA)
- Eastern Cooperative Oncology Group (ECOG) performance score 0 to 2
- Life expectancy more than 14 days
- Adequate liver function: alanine aminotransferase and aspartate transaminase less than or equal to 2.5 times upper limit of normal
- Bilirubin less than 2 times upper limit of normal
- Adequate kidney function: creatinine less than 1.5 times upper limit of normal or creatinine clearance over 40 ml/min
- White blood cell count less than 30 x 10^9/L; hydroxyurea or low-dose cytarabine for up to 3 days allowed for emergency use
You will not qualify if you...
- Previous anti-cancer treatment for AML except hydroxyurea or low-dose cytarabine for emergency use
- Previous treatment with anthracyclines
- Central nervous system involvement
- Isolated extramedullary AML
- Uncontrolled infection
- AML after prior myelodysplasia with previous cytotoxic treatment
- Use of investigational agents within 30 days or 5 half-lives before study start
- Prior treatment with FLT3 inhibitors like midostaurin, quizartinib, or sorafenib
- Use of strong CYP3A4/5 enzyme inducers unless discontinued before enrollment
- Other severe or uncontrolled medical conditions affecting study participation
- Gastrointestinal disorders affecting midostaurin absorption
- Confirmed HIV infection
- Active viral hepatitis unless cleared; specific rules for hepatitis B and C eligibility
- Cardiovascular problems including recent heart attack, uncontrolled arrhythmias, heart failure, low heart function, or poorly controlled hypertension
- Pregnant or nursing women
- Women of childbearing potential not meeting strict contraceptive or pregnancy test requirements
- Sexually active men not using condoms during and for 4 months after treatment
- Known allergy to midostaurin, GO, cytarabine, daunorubicin, or their ingredients
- Inability or unwillingness to follow study protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 21 locations
1
LMU Klinikum, Campus Großhadern
München, Bavaria, Germany, 81377
Actively Recruiting
2
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany, 45147
Actively Recruiting
3
Universitätsklinikum Aachen
Aachen, Germany, 52074
Actively Recruiting
4
Universitätsklinikum Augsburg
Augsburg, Germany, 86156
Not Yet Recruiting
5
Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09116
Actively Recruiting
6
Universitätsklinikum Dresden
Dresden, Germany, 01307
Actively Recruiting
7
Johann Wolfgang Goethe-Universität
Frankfurt am Main, Germany, 60590
Actively Recruiting
8
Universitätsklinikum Halle
Halle, Germany, 06120
Actively Recruiting
9
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
10
Universitätsklinikum Jena
Jena, Germany, 07740
Actively Recruiting
11
Universitätsklinikum Schleswig-Holstein
Kiel, Germany, 24105
Actively Recruiting
12
Gemeinschaftsklinikum Mittelrhein gGmbH
Koblenz, Germany, 56068
Actively Recruiting
13
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Actively Recruiting
14
Klinikum Mannheim gGmbH
Mannheim, Germany, 68167
Actively Recruiting
15
Philipps-Universität Marburg Fachbereich Medizin
Marburg, Germany, 35043
Actively Recruiting
16
Rotkreuzklinikum München gGmbH
München, Germany, 80634
Actively Recruiting
17
Universitätsklinikum Münster
Münster, Germany, 48149
Actively Recruiting
18
Klinikum Nürnberg-Nord
Nuremberg, Germany, 90419
Not Yet Recruiting
19
Krankenhaus Barmherzige Brüder
Regensburg, Germany, 93049
Actively Recruiting
20
Robert-Bosch-Krankenhaus
Stuttgart, Germany, 70376
Actively Recruiting
21
Rems-Murr-Klinikum Winnenden
Winnenden, Germany, 71364
Actively Recruiting
Research Team
C
Christoph Röllig, Prof. Dr.
CONTACT
M
Manja Reimann, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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