Early Clinical Trials (ECT)

Committee Chairman:

Michel Zwaan, Erasmus MC-Sophia Children’s Hospital Rotterdam and Princess Máxima Center, Utrecht, the Netherlands

Committee Members:

Andre Baruchel, Paris
Brigit Nelken, Lille
Yves Bertrand, Lyon
Franco Locatelli, Rome
Carmelo Rizzari, Monza
Pam Kearns, Birmingham
Frank Mussai, Birmingham
Josef Vormoor, Newcastle
Dirk Reinhardt, Essen
Arend von Stackelberg, Berlin
Jean-Pierre Bourquin, Zurich
Michael Dworzak, Vienna
Karsten Nysom, Copenhagen
Henrik Hasle, Aarhus
Barbara de Moerloose, Belgium
Cormac Owens, Dublin

Clinical Trials:

Open:

  • Phase 1b/2 Study of Carfilzomib in Combination with Vincristine, Dexamethasone, PEG‑asparaginase, and Mitoxantrone (R3 induction) in Pediatric Subjects with Relapsed or Refractory Acute Lymphoblastic Leukemia. Sponsored by Amgen.
  • A phase 2 multicenter open label study to evaluate the pharmacokinetics, pharmacodynamics, safety and activity of azacitidine and to compare azacitidine to historical controls in pediatric subjects with newly diagnosed advanced MDS or JMML before HSCT. Protocol AZA-JMML-001. Sponsored by Celgene.
  • Phase 1-2 safety and efficacy study of DACOGEN in sequential combination with cytarabine in children with refractory or relapsed acute myeloid leukaemia. Study JNJ-30979754. Sponsored by Janssen Research.
  • A Phase I, open-label, dose escalation study of LDK378 in pediatric patients with malignancies that have a genetic alteration in anaplastic lymphoma kinase (ALK). Protocol CLDK378X2103. National coordinating investigator. Sponsored by Novartis.
  • A randomized multi center open label phase 2 study with a safety run-in part to evaluate safety, pharmacodynamics and efficacy of azacitidine compared to no anticancer treatment in children and young adults with acute myeloid leukemia in molecular relapse after first complete remission. Protocol AZA-AML-004. Sponsored by Celgene.
  • A multi-center, open label, non-controlled phase II study to evaluate efficacy and safety of oral nilotinib in pediatric patients with newly diagnosed Ph+ chronic myelogenous leukemia (CML) in chronic phase (CP) or with Ph+ CML in CP or accelerated phase (AP) resistant or intolerant to either imatinib or dasatinib. Sponsored by Novartis.
  • A Phase I/II study of Bosutinib in pediatric patients with Chronic Myeloid Leukemia who are resistant or intolerant to at least one prior Tyrosine Kinase Inhibitor therapy”, study ITCC-054. Sponsored by Erasmus MC.
  • A phase I study of Inotuzumab Ozogamicin as a single agent and in combination with chemotherapy for pediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia, study ITCC059. Sponsored by Erasmus MC.
  • A phase 1B of Crizotinib either in combination or as single agent in pediatric patients with ALK, ROS1 or MET positive malignancies. Study ITCC 053, 2016 onwards. Sponsored by Erasmus MC.

Completed:

  • A Randomized, Open-Label, Controlled Phase 3 Adaptive Trial to Investigate the Efficacy, Safety, and Tolerability of the BITE® Antibody Blinatumomab as Consolidation Therapy Versus Conventional Chemotherapy in Pediatric Patients with High-Risk First Relapse of B-precursor Acute Lymphoblastic Leukemia (ALL)”, sponsored by Amgen.
  • Open, non-controlled, dose escalating Phase I trial to evaluate the pharmacokinetics, pharmacodynamics, tolerability and toxicity of volasertib in paediatric patients from 2 years to less than 18 years of age with acute leukaemia or advanced solid tumour, for whom no effective treatment is known. National coordinating investigator. Sponsored by Boehringer-Ingelheim.
  • A Phase 2, Multicentre, Single-arm Study of Moxetumomab Pasudotox inPediatric subjects with Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma of B-cell Origin. CAT-8015-1036. National coordinating investigator, 2014 onwards. Sponsored by Medimmune.
  • A Phase II Study of Dasatinib Therapy in Children and Adolescents with Ph+ Leukemia with Resistance or Intolerance to Imatinib (CA180226). Sponsored by BMS.
  • A phase I study of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL relapse: a joint study of TACL POETIC and ITCC. Sponsored by Erasmus MC in Europe and TACL in North-America.
  • A phase I/II study of clofarabine, daunoxome and cytarabine in relapsed/refractory pediatric AML. Investigator sponsored trial, with Erasmus MC acting as overall sponsor. Sponsored by Erasmus MC.
  • Bortezomib (Velcade®): A feasibility and phase II study in childhood relapsed acute lymphoblastic leukemia. Investigator sponsored trial, with Erasmus MC acting as overall sponsor. Sponsored by Erasmus MC.
  • A phase I/II open label dose-escalating study to determine the safety, tolerability and pharmacokinetics of twice daily oral drink solution of PKC412, and to determine the clinical and pharmacodynamic response in pediatric patients with relapsed or refractory leukemia. Protocol No. PKC412-A2207. Novartis-sponsored study.
  • Phase I/II study of Src/Abl tyrosine kinase inhibitor dasatinib in children and adolescents with relapsed or refractory leukemia, Protocol ITCC 005/BMS CA180018. BMS-sponsored study.
  • Pilot Pharmacokinetic Study of Intravenous and Oral Forodesine Hydrochloride in Children with Relapsed or Refractory T- or B-Lineage Acute Lymphoblastic Leukemia or Non-Hodgkin’s Lymphoma. Protocol No. BCX1777-108 (ITCC Protocol No. 008). Mundipharma sponsored study.
  • A non-randomized open label study to characterize the PK of Glivec in pediatric patients with CML or Ph+-ALL. Sponsored by Novartis.

 

Activities/Projects:

N/A

Recent Publications:

N/A

Meetings:

Recent:

N/A

Next:

Resistant Disease Meeting Newcastle & I-BFM 2017 (10-12 May 2017, Jerusalem)

Contact

Michel Zwaan    c.m.zwaan@erasmusmc.nl