acute lymphoblastic leukemia in children and adolescents 1 to = 18 years of age MedDRA version: 12.1 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia
Conditions
Interventions
Product Name: Adriamycin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: DOXORUBICIN
CAS Number: 23214-92-8
Current Sponsor code: Adriamycin
Other descriptive name: ADR
Product Name:
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children and adolescents aged 1 up to = 18 years with a confirmed diagnosis of acute B-precursor or T-cell leukemia Parent’s or legal guardian’s written informed consent and child’s assent Phase II: high risk ALL defined by MRD load. B-precursor ALL at day 29 = 10-4, T-ALL at day 43 = 10-3 Phase III: MRD positive B-progenitor ALL and T-ALL with MRD = 10-3 at day 29 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ALL diagnosed as second malignancy Cytostatical pre-treatment for more than 1 week Prior severe disease that prohibit treatment according to the protocol Patients with translocation t(9/22) Pregnant or breastfeeding adolescents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase II: Assessment of the efficacy and safety of clofarabine combined with PEG-ASP in high-risk ALL patients Phase III: MRD based randomized assessment of the cytotoxic efficacy of clofarabine compared to high dose-cytarabine each in combination with PEG-ASP During the entire trial duration: Evaluation of the rate of severe infectious complications after ADR versus DNR in re-induction;Secondary Objective: 1st. Comparison of safety profiles of clofarabine/PEG-ASP versus high-dose cytarabine/PEG-ASP 2nd. MRD-based comparison of the efficacy in the high-risk treatment arm between clofarabine/PEG-ASP and high-dose cytarabine/PEG-ASP respectively, and the historical control group MTX/CYC/ASP in protocol COALL 07-03 3rd. Assessment of the impact of MRD-based stratification in COALL 09 on overall and event-free survival compared to historical COALL control groups 4th. Assessment of the overall survival and of the event free survival in a randomized comparison of the therapy arms clofarabine/asparaginase versus high dose-cytarabine in protocol COALL 08-09;Primary end point(s): Trial phase II: assessment and evaluation of the efficacy and safety of the combination treatment clofarabine/PEG-asparaginase in high-risk ALL patients compared to the historical collective with Hidac/PEG-ASP. The following trial phase III: comparison of the efficacies of clofarabine versus high-dose cytarabine. The primary end point will be determined in patients, who reveal a measurable MRD load before intensification therapy. | — |
Countries
Germany
Outcome results
None listed