A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

Sponsor:

COG

Sponsor Study ID:

AAML1831

CTO #:

103312

NCT Number:

NCT04293562

Phase:

III

Protocol Type:

Treatment

Age Group:

Both

Disease Sites:

Myeloid and Monocytic Leukemia

Study Objectives:

This phase III trial compares standard chemotherapy to therapy with CPX-351 and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

eConsent:

Not available

Study Documents:

Open Study Documents
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