Study of Midostaurin and Gemtuzumab Ozogamicin Combined with Standard Chemotherapy for Treating Newly Diagnosed Acute Myeloid Leukemia with Specific Genetic Changes

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining midostaurin and gemtuzumab ozogamicin with standard chemotherapy as a first treatment for patients newly diagnosed with acute myeloid leukemia AML who have specific genetic changes in core-binding factor CBF genes or mutations in the FLT3 gene. This phase III clinical trial aims to improve outcomes in these groups where relapse and resistance to treatment remain challenges. Midostaurin and gemtuzumab ozogamicin target key molecules involved in leukemia cell growth and survival, potentially enhancing treatment effects. The trial includes several parts Phase I MODULE tests increasing doses of midostaurin and gemtuzumab ozogamicin combined with standard chemotherapy drugs cytarabine and daunorubicin. Phase II includes two studies MAGNOLIA compares midostaurin plus chemotherapy and gemtuzumab ozogamicin versus chemotherapy and gemtuzumab ozogamicin alone for CBF AML patients MAGMA compares chemotherapy plus midostaurin and gemtuzumab ozogamicin versus chemotherapy plus midostaurin alone for patients with FLT3 mutations. Doses and schedules vary by study part, with midostaurin taken orally and gemtuzumab ozogamicin given intravenously during induction cycles. Participants will undergo treatment cycles including induction, consolidation, and maintenance phases, with regular monitoring for safety and response. Researchers will assess outcomes such as the highest tolerated dose of the drug combination, event-free survival up to three years, remission rates, relapse rates, overall survival, and early mortality. The study involves frequent clinical visits, laboratory tests, and imaging to track disease status and side effects throughout the treatment and follow-up periods.

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