RecruitingPhase 1Phase 2NCT04385290

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

MidOStaurin + Gemtuzumab OzogAmIcin Combination in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)

Sponsor

Technische Universität Dresden

Enrollment

214 participants

Start Date

Sep 4, 2020

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding gemtuzumab ozogamicin (an antibody-drug targeting leukemia cells) to the standard chemotherapy and midostaurin regimen improves outcomes for people newly diagnosed with acute myeloid leukemia (AML) that has specific genetic features — either CBF mutations (a lower-risk type) or FLT3 mutations (a higher-risk type). **You may be eligible if...** - You are newly diagnosed with AML that has a CBF mutation (t(8;21) or inv(16)) or a FLT3 mutation - You are between 18 and 75 years old (age limits vary by study phase) - Your overall health is good enough to tolerate intensive chemotherapy (ECOG 0-2) - You have adequate liver, kidney, and heart function - You have not previously received chemotherapy for AML (except emergency hydroxyurea) **You may NOT be eligible if...** - You have already received chemotherapy for AML (other than emergency short-term treatment) - You have a prior FLT3 inhibitor treatment (e.g., midostaurin, sorafenib) - You have HIV, active hepatitis B or C - You have active uncontrolled infections - You have significant heart disease (heart attack, heart failure, or serious arrhythmia) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO

Midostaurin (IMP) induction: 25 mg or 50 mg peroral BID, days 8 to 21 depending on assigned dose level GO (IMP) induction: 3 mg/m\^2 i.v. max 4.5 mg, on day1, or on days 1, 4, or days 1, 4, 7 depending on assigned dose level Daunorubicin (DNR, non-IMP) induction: 60 mg/m\^2/day i.v., days 1 to 3 Cytarabine (AraC, non-IMP) induction: 200 mg/m\^2/day cont. infusion, days 1 to 7

DRUGMAGNOLIA-trial: Midostaurin associated with conventional chemotherapy (AraC+DNR)+GO

Midostaurin (IMP): RP2D peroral, days 8 to 21, induction cycle 1; 50 mg peroral BID, days 8 to 21 induction cycle 2; 50 mg peroral BID, days 8 to 21, 3 consolidation cycles; 50 mg peroral BID, days 1 to 28, 12 maintenance cycles; GO (IMP): 3 mg/m\^2 i.v. max 4.5 mg, RP2D, 1 induction cycle only Daunorubicin (DNR, non-IMP): 60 mg/m\^2 i.v., days 1 to 3 of induction cycle 1 and 2 in good and moderate responders; 50 mg/m\^2/day i.v., days 1 to 3 of induction cycle 2 in non-responders Cytarabine (AraC, non-IMP): 200 mg/m\^2/day cont. infusion, days 1 to 7 of induction cycles 1 and 2 in good and moderate responders; 3000/1500 mg/m\^2/day i.v. BID, days 1 to 3 of induction cycle 2 in non-responders; 3000/1500 mg/m\^2 i.v. BID, days 1, 3, 5 of consolidation, 3 cycles

DRUGMAGNOLIA-trial: conventional chemotherapy (AraC+DNR)+GO

GO (IMP): 3 mg/m\^2 i.v. max 4.5 mg on days 1, 4, 7; 1 induction cycle only Daunorubicin (DNR, non-IMP): 60 mg/m\^2/day i.v., days 1 to 3 of induction cycle 1 and 2 in good and moderate responders; 50 mg/m\^2/day i.v., days 1 to 3 of induction cycle 2 in non-responders Cytarabine (AraC, non-IMP): 200 mg/m\^2/day cont. infusion, days 1 to 7 of induction cycles 1 and 2 in good and moderate responders; 3000/1500 mg/m\^2/day i.v. BID, days 1 to 3 of induction cycle 2 in non-responders; 3000/1500 mg/m\^2 i.v. BID, days 1, 3, 5 of consolidation, 3 cycles

DRUGMAGMA-trial:GO associated with conventional chemotherapy (AraC+DNR)+Midostaurin

Midostaurin (IMP): RP2D peroral, days 8 to 21, induction cycle 1; 50 mg peroral BID, days 8 to 21, induction cycle 2; 50 mg peroral BID, days 8 to 21, 3 consolidation cycles; 50 mg peroral BID, days 1 to 28, 12 maintenance cycles; GO (IMP): 3 mg/m\^2 i.v. max 4.5 mg, RP2D, 1 induction cycle only Daunorubicin (DNR, non-IMP): 60 mg/m\^2/day i.v., days 1 to 3 of induction cycles 1-2 in good and moderate responders; 50 mg/m\^2/day i.v., days 1 to 3 of induction cycle 2 in non-responders Cytarabine (AraC, non-IMP): 200 mg/m\^2/day cont. infusion, days 1 to 7 of induction cycles 1 and 2 in good and moderate responders; 3000/1500 mg/m\^2/day i.v. BID, days 1 to 3 of induction cycle 2 in non-responders; 3000/1500 mg/m\^2 i.v. BID, days 1, 3, 5 of consolidation, 3 cycles

DRUGMAGMA-trial: conventional chemotherapy (AraC+DNR)+Midostaurin

Midostaurin (IMP): RP2D peroral, days 8 to 21, induction cycle 1; 50 mg peroral BID, days 8 to 21 induction cycle 2; 50 mg peroral BID, days 8 to 21, 3 consolidation cycles; 50 mg peroral BID, days 1 to 28, 12 maintenance cycles Daunorubicin (DNR, non-IMP): 60 mg/m\^2/day i.v., days 1 to 3 of induction cycle 1 and 2 in good and moderate responders; 50 mg/m\^2/day i.v., days 1 to 3 of induction cycle 2 in non-responders Cytarabine (AraC, non-IMP): 200 mg/m\^2/day cont. infusion, days 1 to 7 of induction cycles 1 and 2 in good and moderate responders; 3000/1500 mg/m\^2/day i.v. BID, days 1 to 3 of induction cycle 2 in non-responders; 3000/1500 mg/m\^2 i.v. BID, days 1, 3, 5 of consolidation, 3 cycles

Locations(21)

LMU Klinikum, Campus Großhadern

München, Bavaria, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Aachen

Aachen, Germany

Universitätsklinikum Augsburg

Augsburg, Germany

Klinikum Chemnitz gGmbH

Chemnitz, Germany

Universitätsklinikum Dresden

Dresden, Germany

Johann Wolfgang Goethe-Universität

Frankfurt am Main, Germany

Universitätsklinikum Halle

Halle, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Universitätsklinikum Jena

Jena, Germany

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

Gemeinschaftsklinikum Mittelrhein gGmbH

Koblenz, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

Klinikum Mannheim gGmbH

Mannheim, Germany

Philipps-Universität Marburg Fachbereich Medizin

Marburg, Germany

Rotkreuzklinikum München gGmbH

München, Germany

Universitätsklinikum Münster

Münster, Germany

Klinikum Nürnberg-Nord

Nuremberg, Germany

Krankenhaus Barmherzige Brüder

Regensburg, Germany

Robert-Bosch-Krankenhaus

Stuttgart, Germany

Rems-Murr-Klinikum Winnenden

Winnenden, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04385290

Related Trials

MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

NCT05564390346 locations

Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)

NCT06317649220 locations

Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

NCT05554406220 locations

Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)

NCT05554393177 locations

Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment

NCT0495389721 locations