автор: Julia Dobke, erstellt am: 2010/09/30, Последнее изменение: 2015/06/11

CoALL-08-09 A randomized multi-center treatment study (COALL 08-09) to improve the survival of children with acute lymphoblastic leukeamia on behalf of the German Society of Pediatric Hematology and Oncology
Формы рака Acute lymphoblastic leukeamia, primary desease
Вид исследования Sequential phase II/III study according to the German drug law (AMG), multi-center trial design including two randomizations
Цель исследования

Primary objectives

  • Assessment of the efficacy and safety of clofarabine combined with PEG-Asparaginase in high-risk ALL patients and MRD based comparison with the historical control group who received High dose Cytarabine /PEG-Asparginase in Phase II
  • MRD based randomized assessment of the cytotoxic efficacy of clofarabine compared to high dose cytarabine each in combination with PEG-Asparaginase in Phase III
  • Evaluation of the rate of severe infectious complications after Adriamycine versus Daunorubicine in re-induction in reinduction therapy

Secondary objectives

  • Comparison of safety profiles of clofarabine/PEG-Asparaginase versus high-dose cytarabine/PEG-Asparaginase
  • MRD-based comparison of the efficacy in the high-risk treatment arm between clofarabine/PEG-Asparaginase and high-dose cytarabine/PEG-Asparaginase respectively, and the historical control group Methotrexate/Cyclofosphamide/Asparaginase in protocol COALL 07-03
  • Assessment of the impact of MRD-based stratification in COALL 09 on overall and event-free survival compared to historical COALL control groups

The CoALL-08-09 trial is a prospective, multicenter therapy-optmizing trial with the purpose to optimize the prognosis for children with acute lymphoblastic leukeamia. Depending of prognostic risk factors the patients will be stratified into the low-risk group or the high risk-group. A second stratification follows after the knowledge of the result of MRD on day 29 for patients with a B-progenitor ALL or day 43 for patients with a T-ALL.

A 3-drug-induction is followed by several sequentially administered cycles of combination chemotherapy . In phase II all high risk patients receive Clofarabin/PEG-Asparaginase without randomisation. In phase III the 1st randomization is: clofarabine (40 mg/m2) on day 29-33 + PEG-Asparaginase 2 500 IE/m2 on day 33 versus High dose Cytarabin (HIDAC: 4x3g/m2) on day 29 - 31 + PEG-Asparaginase 2 500 IE/m2 on day 31.
The 2nd randomization is: Daunorubicine 36 mg/m2 versus Adriamycine 30 mg/m2 on day 1 and 8 in the standard arm, on day 22 and 29 in the high-risk arm.

A quarter of all patients with B -precursor ALL don´t show any measurable MRD at the end of induction. These patients will not be part of the first randomization. Just as well will patients with a T-ALL and a MRD on day 29 < 10-3be excluded from this randomization.

Кого берут в протокол
  • Children and adolescents aged >1 and < 18 years with a confirmed diagnosis of acute B- progenitor or T-cell leukemia
  • Parents or legal guardians written informed consent and child’s assent
  • Phase II: high risk ALL defined by MRD load. B-progenitor ALL at day 29 >=10-4, T-ALL at day 43 >=10-3
  • Phase III: MRD positive B-progenitor ALL und T-ALL with MRD >= 10-3 at day 29
  • Infants and patients with a philadelphia chromosome positive ALL will receive different therapy trials
Кого не берут в протокол

Für die Therapie mit Clofarabin:

  • Phase II: B-Vorläufer ALL mit d 29 MRD <10-4 und T-ALL mit d 43 MRD <103
  • Phase III: d 29 MRD negative B-Vorläufer ALL und T-ALL mit d 29 MRD < 103
Сколько пациентов должно пройти через исследование ca. 110 Patienten per year
Status 01.10.2010-30.09.2016
Руководитель протокола Prof. Dr. Martin Horstmann
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Участники исследования 10 Kliniken
Кто финансирует Fördergemeinschaft Kinderkrebszentrum Hamburg e.V., Genzyme
Die Studie trägt das Gütesiegel A des Studienhauses Onkologie der deutschen Krebsgesellschaft vor