PIVEKIMAB SUNIRINE
Sponsors
AbbVie Deutschland GmbH & Co. KG, Fred Hutchinson Cancer Center, AbbVie
Conditions
Acute Myeloid LeukemiaAcute Myeloid Leukemia and other blood cancersCD123 positive Acute Myeloid LeukemiaMixed Phenotype Acute LeukemiaMyelodysplastic SyndromeMyelodysplastic/Myeloproliferative NeoplasmMyeloproliferative NeoplasmRelapsed or Refractory Acute Myeloid Leukemia; Acute Myeloid Leukemia
Phase 1
Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms
Active, not recruitingNCT06034470
Start: 2023-12-18End: 2029-05-31Updated: 2026-07-29
A Phase 1/2, Multicenter, Open-label Study of IMGN632 Monotherapy Administered Intravenously in Patients with CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies
Active, not recruitingCTIS2024-514195-40-00
Start: 2019-02-28Target: 34Updated: 2026-01-19
A Phase 1b/2 Study of IMGN632 as Monotherapy or Combination with Venetoclax and/or Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia
Active, not recruitingCTIS2024-514197-50-00
Start: 2020-01-17Target: 68Updated: 2025-12-19
A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
RecruitingNCT07306832
Start: 2026-05-20End: 2030-03-01Target: 18Updated: 2026-09-09
A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML).
Not yet recruitingCTIS2024-520125-36-00
Target: 1Updated: 2026-04-20
Phase 2
A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML)
RecruitingNCT07581002
Start: 2026-06-30End: 2032-06-01Target: 660Updated: 2026-09-15
A Randomized Phase 2/3 Study Evaluating the Safety and Efficacy of Pivekimab Sunirine (PVEK) in Combination with Venetoclax and Azacitidine in Adult Subjects with Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible to Receive Intensive Chemotherapy
Not yet recruitingCTIS2025-523724-47-00
Target: 8Updated: 2026-08-03