Completed Trials

Completed studies ALL

IDH (1991-1995): SR ALL
Pulses (1995-2000): MR ALL
HSCT in VHR ALL (1995-2000)
AIEOP-BFM ALL (2000-2006): ALL
Interfant-99 (1999-2006): ALL below the age of one year (ALL<1y)
EsPhALL* (2004-2009): ALL positive for the t(9;22) translocation

Completed studies AML

Methotrexate in relapsed and refractory childhood AML – a therapeutic window study (1999-2003)
Relapsed AML 2001/01 (2001-2009)
A phase II study on Mylotarg in childhood relapsed and refractory AML (2002-2006)

Completed studies NHL

I-BFM NHL LL 2009 (Study Chair: J. Sterba, Slovakia)
B-NHL BFM 2004 (Study Chair: A. Reiter, Germany)
NHL-BFM 90 (1990-95)
NHL-BFM 95 (1995-2004)
EURO-LB 02 (2004-2008)

Therapy optimization studies in collaboration with EICNHL

ALCL 99 (analysed)
EURO-LB02 (completed, analysed)

Studies Resistant Disease

IntReALL 2010

Completed ECT Studies

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.