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267 : First Results of an Open Label Phase II Study to Evaluate the Efficacy and Safety of Inotuzumab Ozogamicin for Induction Therapy Followed By a Conventional Chemotherapy Based Consolidation and Maintenance Therapy in Patients Aged 56 Years and Older with Acute Lymphoblastic Leukemia (INITIAL-1 trial)

Researchers

Presenter

  • Matthias Stelljes

Principal Investigators

  • Simon Raffel

  • Ralph Wsch

  • Sebastian Scholl

  • Mustafa Kondakci

  • Andreas Rank

  • Mathias Haenel

  • Sonja Martin

  • Katjana Schwab

  • Julian Knaden

  • Klaus Wethmar

  • Tim Sauer

  • Wolfgang E. Berdel

  • Georg Lenz

  • Martin Dugas

  • Monika Brggemann

  • Nicola Goekbuget

  • Nael Alakel

Medical Centers

  • Department of Nuclear Medicine, University Hospital Muenster, Muenster, Germany

  • Departement of Nuclear Medicine, University of Heidelberg, Heidelberg, Germany

  • Department of Medicine, Division Hematology and Oncology, University of Freiburg Medical Center, Freiburg, Germany

  • Universitatsklinikum Jena, Jena, Germany

  • Department of Hematology, Oncology and Clinical Immunology, Universitaetsklinikum Duesseldorf, Duesseldorf, Germany,

  • Klinikum Augsburg, Augsburg, DEU

  • Klinikum Chemnitz, Chemnitz, Germany

  • Department of Hematology and Oncology, Katharinenhospital, Stuttgart, Germany

  • University Hospital Bonn, Bonn, Germany

  • University Hospital Frankfurt, Frankfurt, Germany

  • University Hospital Muenster, Muenster, DEU

  • Medizinische Klinik V, Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany

  • Department of Nuclear Medicine, University Hospital Muenster, Muenster, Germany

  • Department of Nuclear Medicine, University Hospital Muenster, Muenster, Germany

  • Institute of Medical Informatics, University of Muenster, Muenster, Germany

  • Department of General Pediatrics, University Hospital Schleswig-Holstein, Kiel, Germany

  • University Hospital, Department of Medicine II, Hematology/Oncology, Head of Study Center Depart of Medicine II, Hematology/Oncology Goethe University Hospital, Frankfurt, Germany

  • Essen University Hospital, Essen, Germany

Locations

  • Germany

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

  • Blood/haematological Diseases

Disease

  • Acute lymphoblastic leukemia

  • B lymphoblastic leukemia

  • Acute Leukemia

Biomarkers

  • B-lymphocyte antigen CD20

Drug/Treatment

  • Inotuzumab ozogamicin

  • Cyclophosphamide

  • Cyclophosphamide Injection

  • 6-mercaptopurine

  • Allmercap

  • Dexamethasone

  • Dekpak 13 Day Taperpak

  • Methotrexate

  • Asparaginase

  • Vincristine

  • Cytarabine liposomal

  • Rituximab

Outcome

  • N/A


Study Design

  • Open Label

  • Multicenteric

Phase

  • II

Study Id's

  • NCT03460522

Sponsors

  • N/A

Result

  • N/A