EUCTR2007-004270-43-DE
Active, not recruiting
Phase 1
International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia - AIEOP-BFM ALL 2009
niversitätsklinikum Schleswig-Holstein, Campus Kiel0 sites4,950 target enrollmentOctober 23, 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- acute lymphoblastic leukemia in children and adolescents 1 to <18 years of age
- Sponsor
- niversitätsklinikum Schleswig-Holstein, Campus Kiel
- Enrollment
- 4950
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. newly diagnosed acute lymphoblastic leukemia
- •2\. age \= 1 year (\> 365 days) and \< 18 years (up to 17 years and 365 days)
- •3\. no Ph\+ (BCR/ABL or t(9;22\)\-positive) ALL
- •4\. no evidence of pregnancy or lactation period
- •5\. no participation in another clinical study
- •6\. patient enrolled in a participating center
- •7\. written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
Exclusion Criteria
- •1\. pre\-treatment with cytostatic drugs
- •2\. steroid pre\-treatment with \= 1 mg/kg/d for more than two weeks during the last month before diagnosis
- •3\. treatment started according to another protocol
- •4\. underlying diseases that prohibit treatment according to the protocol
- •5\. ALL diagnosed as second malignancy
Outcomes
Primary Outcomes
Not specified
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