Ongoing Trials

Ongoing studies ALL

INTERFANT-06: Randomized clinical trial for ALL under 1y*
ALLIC-BFM 2002 (2002-2009 ): Randomized clinical protocol for ALL in countries with limited resources
ALL-SCT BFM 2003: HSCT* in VHR ALL
AIEOP-BFM ALL 2009: Randomized clinical trial for ALL (age 1-18y) Germany
ALL IC-BFM 2009
*web-based trials

Ongoing studies AML

ICC APL Study 01
Down Syndrome ML 2006
Relapsed AML 2010/01 (start Dec 2012)

Ongoing studies NHL

B-NHL BFM / NOPHO trial 2013 (Study Chairs: B. Burkhardt, Germany – K. Mellgren, Sweden)
I-BFM NHL LL 2009
B-NHL BFM 04
B-NHL BFM Rituximab
I-BFM rare paediatric NHL data registry

Ongoing studies ECT

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.

Ongoing Studies SCT

ALL SCT BFM International, Allogeneic Stem Cell Transplantation for Children and Adolescents with ALL, Prospective international controlled comparative non-randomized study.

ALL SCT PED 2012 Forum (for omitting radiation under majority age). Allogeneic Stem Cell Transplantation in Children and Adolescents with ALL in CR. Prospective controlled randomized international study.

CML SCT I-BFM: Multicenter Study: Prospective controlled multi-center therapy optimization study for children with CML undergoing SCT. Prospective international single-arm study.

Role of MRD in ALL after SCT: Retrospective observational multi-center WIG joint I-BFM/EBMT and COG/PBMTC study for assessing the role of post-transplant MRD in children with ALL.

Refractory NHL management within I-BFM. A retrospective I-BFM study.

AML post transplant relapse. A retrospective I-BFM study.

AML eligibility criteria for transplantation: an I-BFM Survey. Survey circulated among SCT Committee Members regarding SCT eligibility criteria in AML pediatric patients

Therapy optimization studies in collaboration with EICNHL

ALCL-Relapse