INTERNATIONAL COLLABORATIVE TREATMENT PROTOCOL FOR CHILDREN AND ADOLESCENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA - AIEOP-BFM ALL 2009

• Conditions: Acute Lymphoblastic Leukemia; MedDRA version: 9.1Level: LLTClassification code 10001690

• Registration Number: EUCTR2007-004270-43-IT
• Lead Sponsor: IVERSITY HOSPITAL SCHLESWIG-HOLSTEIN CAMPUS KIE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-02
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 4750

Inclusion Criteria

- newly diagnosed acute lymphoblastic leukemia - age = 1 year (> 365 days) and < 18 years (up to 17 years and 365 days) - no Ph+ (BCR/ABL or t(9;22)-positive) ALL - no evidence of pregnancy or lactation period - no participation in another clinical study - patient enrolled in participating center - 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
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

- pre-treatment with cytostatic drugs, - steroid pre-treatment with = 1 mg/kg/d for more than two weeks during the last month before diagnosis, - treatment started according to another protocol, - underlying diseases that prohibit treatment according to the protocol (e.g. severe congenital heart disease, Charcot-Marie Syndrome, Ataxia-teleangectasia…), - ALL diagnosed as second malignancy.

Study & Design

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