Titre An Open-label, Multicenter, Phase 1b Study of JNJ-74494550 (Cusatuzumab; Anti-CD70 Monoclonal Antibody) in Combination With Background Therapy for the Treatment of Subjects With Acute Myeloid Leukemia
Protocole ID ELEVATE
ClinicalTrials.gov ID NCT04150887
Type(s) de cancer Leucémie myéloïde aiguë (LMA)
Phase Phase I
Type étude Traitement
Médicament Cusatuzumab + Azacitidine vs Cusatuzumab + Venetoclax vs Cusatuzumab + Venetoclax + Azacitidine
Institution CENTRE UNIVERSITAIRE DE SANTE MCGILL
   SITE GLEN
      1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville Montréal
Investigateur(trice) principal(e) Dr John Storring
Coordonnateur(trice) Henry Nchienzia
514-934-1934
Statut Actif en recrutement
Critètes d'éligibilité
  • Diagnosis of acute myeloid leukemia (AML) according to World Health Organization 2016 criteria . Participants with acute promyelocytic leukemia (APL) with t (15;17) or its molecular equivalent (promyelocytic leukemia/retinoic acid receptor alpha [PML RAR alpha]) are not eligible
  • Must be ineligible for intensive chemotherapy
  • De novo or secondary AML
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Previously untreated AML except: emergency leukapheresis, hydroxyurea, and/or 1 dose 1-2 gram per meter square (g/m^2) cytarabine during the Screening Phase to control hyperleukocytosis. These treatments must be discontinued greater than or equal to (>=) 24 hours prior to start of study drug. Empiric all trans retinoic acid (ATRA) treatment for presumed acute promyelocytic leukemia (APL) is permitted but APL must be ruled out and ATRA must be discontinued >=24 hours prior to the start of study drug
  • Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
Critètes d'exclusion
  • Leukemic involvement of the central nervous system
  • Eligible for an allogeneic hematopoietic stem cell transplantation at study entry
  • Received a live, attenuated vaccine within 4 weeks prior to initiation of study drug
  • A history of human immunodeficiency virus (HIV) antibody positive or tests positive for HIV if tested at screening
  • Known allergies, hypersensitivity, or intolerance to cusatuzumab, venetoclax, azacitidine, or their excipients (example: mannitol, an excipient of azacitidine)