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

Phase 1 Study of FLAG-Ida With Pivekimab Sunirine (PVEK [IMGN632]) for Adults With Newly Diagnosed Adverse-Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial finds the best dose of PVEK when given together with fludarabine, cytarabine, granulocyte colony-stimulating factor (G-CSF), and idarubicin, (FLAG-Ida) regimen and studies the effectiveness of this combination therapy in treating patients with newly diagnosed adverse risk acute myeloid leukemia (AML) and other high-grade myeloid neoplasms. PVEK is a monoclonal antibody linked to a chemotherapy drug. PVEK is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD123 receptors, and delivers the chemotherapy drug to kill them. Chemotherapy drugs, such as idarubicin, fludarabine, high-dose cytarabine 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. G-CSF helps the bone marrow make more white blood cells in patients with low white blood cell count due to cancer treatment. Giving PVEK with the FLAG-Ida regimen may be a safe and effective treatment for patients with acute myeloid leukemia and other high-grade myeloid neoplasms.

Detailed description

OUTLINE: This is a dose-escalation study of PVEK. INDUCTION THERAPY: Patients receive PVEK intravenously (IV) on day 1 or day 1 and 22. Patients also receive G-CSF subcutaneously (SC) on days 0-5, fludarabine IV over 30 minutes on days 1-5, cytarabine IV over 2 hours on days 1-5, and idarubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients who still have cancer after the first cycle of study treatment may receive an additional cycle of induction chemotherapy with PVEK. Patients who go into remission after the first 1 or 2 cycles of study continue to Post-Remission Therapy. POST-REMISSION THERAPY: Patients receive PVEK IV on day 1 or day 1 and 22 of each cycle and high-dose cytarabine IV every 12 hours on days 1-6 of each cycle. Treatment repeats every 42 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and may undergo bone marrow biopsy and blood sample collection throughout the trial. Patients also undergo echocardiography (ECHO) or multigated acquisition (MUGA) scan during screening and as clinically indicated on trial. After completion of study treatment, patients are followed every 3 months for 5 years.

Conditions

• Acute Myeloid Leukemia
• Mixed Phenotype Acute Leukemia
• Myelodysplastic Syndrome
• Myelodysplastic/Myeloproliferative Neoplasm
• Myeloproliferative Neoplasm

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-12-18
• Primary completion: 2026-05-31
• Completion: 2029-05-31
• First posted: 2023-09-13
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study