International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia - AIEOP-BFM ALL 2009

Phase 1

• Conditions: acute lymphoblastic leukemia in children and adolescents at age = 1 year4 (> 365 days) and < 18 years (up to 17 years and 365 days); MedDRA version: 8.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemia

• Registration Number: EUCTR2007-004270-43-CZ
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein, Campus Kiel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-02
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4950

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
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

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

Study & Design

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