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: Isatuximab in Combination with Chemotherapy in Pediatric Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia (ISAKIDS): Interim Analysis

Researchers

Presenter

  • Andre Baruchel

Principal Investigators

  • Yves Bertrand

  • Oscar Gonzalez

  • Karsten Nysom

  • Willy Quinones

  • Carmelo Rizzari

  • Jochen Buechner

  • Simone Cesaro

  • Joaquin Duarte

  • Franca Fagioli

  • Hyoung Jin Kang

  • Antonis Kattamis

  • Guy Leverger

  • Kathleen Ludwig

  • Monica L Makiya

  • Concetta Micalizzi

  • Brigitte Nelken

  • Camilla Tøndel

  • Keon Hee Yoo

  • Inna Ivanina

  • Claire Brillac

  • Lynn Wang

  • Corina Oprea

  • Giovanni Abbadessa

  • C. Michel Zwaan

Medical Centers

  • Pediatric Hematology-Oncology Unit, MBBM Foundation, ASST Monza, University of Milano-Bicocca, Monza, Italy

  • Division of Pediatric Onco-hematology, Regina Margherita-S. Anna Hospital, Turin, Italy

  • Princess Máxima Center for Pediatric Oncology, Utrecht, Netherlands

  • Centro Médico Monte Carmelo, Arequipa, Peru

  • Istituto Ospedaliero Giannina Gaslini, Genova, Italy

  • Department of Pediatrics, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden

  • Department of Pediatric Hematology and Oncology, Oslo University Hospital, OSLO, NOR

  • Sanofi Translational Medicine & Early Development, Paris, France

  • Sanofi Research and Development, Vitry-Sur-Seine, France

  • Hospital Italiano de Buenos Aires, Buenos Aires, ARGENTINA

  • Children's Medical Center, Dallas

  • Haukeland University Hospital, Bergen, Norway

  • Madero y Gonzalitos S/N, Monterrey, Nuevo León, Mexico

  • The Pediatric Hematology-Oncology, Department of Mother and Child, Azienda Ospedaliera Universitaria Integrata, Verona, Italy

  • Instituto Portugues de Oncologia de Lisboa, Lisbon, Portugal

  • Institute of Hematology and Oncology Pediatrics, University Hospital of Lyon, Lyon, France

  • Hopital Jeanne de Flandre, Lille, France

  • Pediatric Hematology Oncology Immunology Department, Armand-Trousseau University Hospital, AP-HP, Paris, France

  • Pediatric Hematology Oncology Unit, First Department of Pediatrics, National and Kapodistrian University of Athens, Aghia Sophia Children's Hospital, Athens, Greece

  • Dep. of Pediatrics, Samsung Medical Center, Seoul, Korea, Republic of (South)

  • University Hospital Rigshospitalet, Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark

  • Department of Pediatrics, Seoul National University Hospital, Seoul, Korea, Republic of (South)

  • Hôpital Universitaire Robert Debré (APHP) and Université de Paris, Paris, France

Locations

  • Italy

  • United States

  • Norway

  • Mexico

  • Netherlands

  • Peru

  • Portugal

  • Greece

  • France

  • Sweden

  • Republic of South Korea

  • Denmark

  • Argentina

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Acute lymphoblastic leukemia

  • Acute myelocytic leukemia

  • B-cell acute lymphoblastic leukemia

  • T-cell acute lymphoblastic leukemia

Biomarkers

  • Cluster of Differentiation 38

  • Granulocyte colony-stimulating factor

Drug/Treatment

  • fludarabine tablet

  • Cytarabine liposomal

  • Isatuximab

  • Filgrastim

Outcome

  • N/A

Study Design

  • Safety

  • Pharmacokinetics

  • Open Label

  • Single Arm

  • Multicenteric

Phase

  • II

Study Id's

  • N/A

Sponsors

  • N/A

Result

  • N/A

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