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Ongoing research in paediatric CML

We are aware about the following current ongoing studies in pediatric CML:

 

The International Study of chronic myeloid leukemia (CML) Treatment and Outcomes in Children and Adolescents (I-CML-Ped Study) (Eudract number: 2010-023359-27, Protocol Code Number CIC09-33PediatricCMLRegistry) - worldwide registry for pediatric CML initiated in January 2011. Led by Dr Frédéric MILLOT, CHU de Poitiers, 86 000 Poitiers France - cases to be submitted to him via National Coordinators (preferred) or individually by the centers.

 

European CML-Paed-II study: prospective, multicentric, not randomized therapy optimization study, 2007 - 2013, coordinated by Prof. Dr. Meinolf Suttorp. 75 patients recruited by January 2011, still recruiting. The researchers observed imatinib treatment results in high response rates, while side effects are tolerable, suggesting BMT should become 2nd line. However impact on bone metabolism, decreasing bone growth, needs further research.

 

Glivec in Pediatric Chronic Myeloid Leukemia (CML), run by Poitiers University Hospital, ClinicalTrials.gov NCT00845221, started in 2004, recruiting 44 patients until Dec 2011. Phase 4 study, not randomised and multicentric. Within 2 months after the diagnosis, the patients daily receive imatinib by oral way during at least 1 year, i.e. until the cytogenetic analysis. Beyond 1 year of treatment, if a hematological relapse or a loss of the cytogenetic response is observed, the nature of the treatment suggested to the patient is left with the appreciation of the investigator. Later on, discontinuation of imatinib is discussed if a molecular remission (negative RT-PCR) is obtained and maintained for at least 2 years.


CA180018 trial: EMA-approved Pediatric Investigation Plan - stratified phase 1 dose-escalation study with dasatinib aimed at improving outcomes in pediatric leukemias, conducted via the ITCC consortium in 7 countries (15 centers). The primary aim is to establish a safe and effective phase 2 dose of dasatinib in children/adolescents with subtypes of relapsed/refractory leukemia. Secondary objectives include safety, pharmacokinetics (PK), and rates of hematologic, cytogenetic, and molecular response. First results published at ASH 2010, 50 patients recruited 2006-2009, 17 patients in CML-CP, 17 in CML-AP, AML-BP and ph+ALL (ASH2010-abstract 2265)

 

CA180038 trial: A Phase I Study of BMS-354825 in Children With Recurrent/Refractory Solid Tumors or Imatinib Resistant Ph+ Leukemia. Recruitment ended 2009, 48 patients enrolled, 9 patients with CML and 2 with ph+ALL.  More information (stanford.edu)

 

Please also see the list of published scientific articles about pediatric CML.