International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004270-43-DE

Enrollment

4950

Registered

2009-10-23

Start date

Unknown

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute lymphoblastic leukemia in children and adolescents 1 to <18 years of age MedDRA version: 20.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864

Interventions

Product Name: 6-Mercaptopurine Pharmaceutical Form: Tablet INN or Proposed INN: Mercaptopurine CAS Number: 50-44-2 Current Sponsor code: 6-Mercaptopurine Product Name: Thioguanine Pharmaceutical Form

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. newly diagnosed acute lymphoblastic leukemia 2. age = 1 year (> 365 days) and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. Non-HR pB-ALL patients with TEL/AML1-negative ALL or unknown TEL/AML1 status and FCM-MRD in bone marrow on day 15 < 0.1 % or with TEL/AML1-positive ALL (randomized study question): can the daunorubicin dose in Protocol IA be safely reduced by 50 % with a non-inferior EFS and a reduction of toxicity (treatment-related mortality and AE/SAE in Protocol I)? 2. Patients with precursor-B ALL and risk group MR (randomized study question): can the clinical outcome be improved by protracted asparagine depletion achieved through application of intensified pegylated L-asparaginase during reintensification and early maintentance? 3. High Risk patients (as identified by day 33 - randomized study question): can the clinical outcome be improved by protracted exposure to PEG-L-asparaginase during Protocol IB? ;Secondary Objective: 1. Standard risk pts identified by at least one sensitive marker: Is the clinical outcome comparable to that obtained in SR pts AIEOP-BFM ALL 2000, or can the outcome even be improved with the use of PEG-L-asparaginase instead of native E. coli L-Asparaginase? 2. T-ALL non HR pts: Can the high level of outcome obtained in study AIEOP-BFM ALL 2000 be preserved or even improved with the use of PEG-L-ASP instead of native E.coli L-ASP? 3. HR pts with persistingly high MRD levels: Is it possible to improve the outcome and to achieve a further reduction of leukemic cell burden by administration of an innovative treatment schedule (DNX-FLA) 4. Pts participating in the randomized asparaginase studies: Are ASP activity and ASP antibodies associated with allergic reactions, and do they have an effect on the outcome? 5. What is the relative value of different methods of MRD monitoring in the definition of alternative stratification systems within a BFM-oriented protocol?;Primary end point(s): 1. Randomization R1: Event-free survival from time of randomization 2. Randomization R2: Disease-free survival from time of randomization 3. Randomization R	—

Measure

Time frame

Main Objective: 1. Non-HR pB-ALL patients with TEL/AML1-negative ALL or unknown TEL/AML1 status and FCM-MRD in bone marrow on day 15 < 0.1 % or with TEL/AML1-positive ALL (randomized study question): can the daunorubicin dose in Protocol IA be safely reduced by 50 % with a non-inferior EFS and a reduction of toxicity (treatment-related mortality and AE/SAE in Protocol I)? 2. Patients with precursor-B ALL and risk group MR (randomized study question): can the clinical outcome be improved by protracted asparagine depletion achieved through application of intensified pegylated L-asparaginase during reintensification and early maintentance? 3. High Risk patients (as identified by day 33 - randomized study question): can the clinical outcome be improved by protracted exposure to PEG-L-asparaginase during Protocol IB? ;Secondary Objective: 1. Standard risk pts identified by at least one sensitive marker: Is the clinical outcome comparable to that obtained in SR pts AIEOP-BFM ALL 2000, or can the outcome even be improved with the use of PEG-L-asparaginase instead of native E. coli L-Asparaginase? 2. T-ALL non HR pts: Can the high level of outcome obtained in study AIEOP-BFM ALL 2000 be preserved or even improved with the use of PEG-L-ASP instead of native E.coli L-ASP? 3. HR pts with persistingly high MRD levels: Is it possible to improve the outcome and to achieve a further reduction of leukemic cell burden by administration of an innovative treatment schedule (DNX-FLA) 4. Pts participating in the randomized asparaginase studies: Are ASP activity and ASP antibodies associated with allergic reactions, and do they have an effect on the outcome? 5. What is the relative value of different methods of MRD monitoring in the definition of alternative stratification systems within a BFM-oriented protocol?;Primary end point(s): 1. Randomization R1: Event-free survival from time of randomization 2. Randomization R2: Disease-free survival from time of randomization 3. Randomization R

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Countries

Austria, Czech Republic, Germany, Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026