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Phase 3
Age: 0 - 17Years
All Genders
ID03643276

International Study of New Treatments for Children and Adolescents With Acute Lymphoblastic Leukemia Using Chemotherapy and Immunotherapy

Led by Martin Schrappe · Updated on 2025-04-06

5000

Participants Needed

115

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying acute lymphoblastic leukemia ALL in children and adolescents, recognizing it as a diverse disease with complex genetic features. The study aims to improve treatment by using more precise risk assessments and testing immunotherapy as an alternative to intensive chemotherapy, especially for patients at high risk of relapse. It also explores targeted therapy to overcome chemotherapy resistance and evaluates extended chemotherapy for T-cell ALL patients with slower treatment responses. The study divides patients into risk groups based on leukemia type, genetics, and treatment response, then tests different experimental treatments alongside standard chemotherapy. These include the proteasome inhibitor bortezomib during consolidation for high-risk B-cell ALL, immunotherapy with blinatumomab replacing intensive chemotherapy in high-risk patients, and blinatumomab for intermediate-risk patients. T-cell ALL patients receive extended consolidation chemotherapy to reduce relapse risk. Participants undergo a series of treatment phases including induction, consolidation, extra-compartment, reinduction, and maintenance therapy lasting up to two years after diagnosis. Treatments include various chemotherapy drugs and immunotherapy cycles depending on the assigned group. Researchers monitor outcomes such as event-free and disease-free survival over up to ten years, along with treatment toxicity and minimal residual disease response. Some high-risk patients may receive stem cell transplants or cranial irradiation as part of their treatment plan.

CONDITIONS

Brief Title

Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017

Research Team

A

Anja Möricke, MD

L

Lile Bauer

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