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Clinical Trials/EUCTR2007-004270-43-DE
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.

Registry
who.int
Start Date
October 23, 2009
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversitätsklinikum Schleswig-Holstein, Campus Kiel

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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