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Clinical trial

A Phase 3, Multicenter, Open-label, Randomized, Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes With Excess Blasts-2 (MDS-EB2) With FLT3 Mutations Eligible for Intensive Chemotherapy (HOVON 156 AML / AMLSG 28-18)

NCT04027309 is registered in ClinicalTrials.gov with Stichting Hemato-Oncologie voor Volwassenen Nederland as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3, Multicenter, Open-label, Randomized, Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes With Excess Blasts-2 (MDS-EB2) With FLT3 Mutations Eligible for Intensive Chemotherapy (HOVON 156 AML / AMLSG 28-18)
Lead sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Phase
Phase 3
Overall status
Active, not recruiting
Start date
December 20, 2019
Completion date
June 30, 2033
Enrollment
777 (actual)
Sites
193

Conditions

As the registry lists them; a condition with its own page is linked.

acute myeloid leukemia, myelodysplastic syndrome with excess blasts-2