NCT06034470 - Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK [IMGN632]) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 18, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions

Acute Myeloid LeukemiaMixed Phenotype Acute LeukemiaMyelodysplastic SyndromeMyelodysplastic/Myeloproliferative NeoplasmMyeloproliferative Neoplasm

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspirate

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Cytarabine

Given IV

PROCEDURE

Echocardiography

Undergo ECHO

DRUG

Fludarabine

Given IV

DRUG

Granulocyte Colony-Stimulating Factor

Given SC

DRUG

Idarubicin

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

DRUG

Pivekimab Sunirine

Given IV

Trial Locations (1)

RECRUITING

Fred Hutch/University of Washington Cancer Consortium, Seattle