EUCTR2009-012758-18-DE
Active, not recruiting
Not 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 sitesJanuary 4, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- acute lymphoblastic leukemia in children and adolescents 1 to = 18 years of age
- Sponsor
- niversitätsklinikum Hamburg-Eppendorf
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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