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

• Conditions: acute lymphoblastic leukemia in children and adolescents 1 to = 18 years of age; MedDRA version: 12.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemia

• Registration Number: EUCTR2009-012758-18-DE
• Lead Sponsor: niversitätsklinikum Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified