EUCTR2009-012758-18-DEActive, not recruitingNot Applicable
A randomized multi-center treatment study (COALL 08-09) to improve the survival of children with acute lymphoblastic leukemia on behalf of the German Society of Pediatric Hematology and Oncology - COALL 08-09
niversitätsklinikum Hamburg-Eppendorf0 sitesStarted: January 4, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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