Deutsches Leukämie-Studienregister
Studie: Elevate

Kurzübersicht
Öffentlicher Titel Phase I Studie zu Cusatuzumab bei akuter myeloischer Leukämie
Wissenschaftl. Titel 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
Kurztitel Elevate
Studiennummer KN/ELN LN_NN_2020_704
Studiengruppe NN
Studienart multizentrisch, prospektiv, offen
Studienphase Phase I
Erkrankung Akute myeloische Leukämie (AML) - AML alle außer FAB M3
Leukämiestadium de novo/non-treated
Einschlusskriterien
  • Diagnosis of acute myeloid leukemia (AML) according to World Health Organization 2016 criteria . Participants with acute promyelocytic leukemia (APL) 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
Ausschlusskriterien
  • 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)
Alter >= 18 Jahre
Status Aktiv
Beginn der Rekrutierung 17.09.2020
Kurzprotokoll Kurzprotokoll
Sponsoren Janssen
Registrierung in anderen Studienregistern ClinicalTrials.gov NCT04150887
European Clinical Trials Database - EUDRACT 2019-002808-41
erstellt 19.11.2020 Zenawit Krüger
geändert 30.12.2020 Student Studienregister
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