Clinical trials on Childhood Acute Lymphoblastic Leukemia

  • CT-EU-00111584

    2015 Moscow-Berlin Study on New Treatments for Childhood Acute Lymphoblastic Leukemia

    The Moscow-Berlin 2015 Multicenter Randomized Study for Treatment of Acute Lymphoblastic Leukemia in Children, Adolescents, and Young Adults (ALL-MB 2015) is a comprehensive clinical trial aimed at exploring new treatment strategies for Childhood Acute Lymphoblastic Leukemia. The study focuses on several key objectives to enhance the effectiveness and feasibility of treatments across different age groups, particularly in young adults and adolescents.

    One of the main goals is to test whether a new risk group stratification, especially for T-ALL, can improve overall and event-free survival rates. The study also examines the effectiveness of intermittent dexamethasone administration during the induction phase to see if it can reduce toxicity and mortality without compromising efficacy. Additionally, the trial investigates the impact of using methylprednisolone as the primary glucocorticoid during induction, consolidation, and maintenance therapy to potentially decrease severe infections and early mortality rates, thereby improving survival and therapy compliance in adolescents and young adults with B-precursor ALL.

    Another significant aspect of the study is the administration of Bortezomib in patients with B-precursor ALL who have an initial WBC count of ≥100,000/µl, to assess if it can improve treatment outcomes. Furthermore, the trial explores the substitution of Idarubicin for Daunorubicin in low-risk T-ALL patients and the implementation of a two-phase induction in intermediate-risk T-ALL patients to see if these strategies can reduce the relapse rate and enhance survival.

    The study employs various drugs in its treatment protocols, including Dexamethasone, Methylprednisolone, Daunorubicin, Idarubicin, Bortezomib, and others, administered in specific dosages and schedules tailored to the phase of treatment—ranging from induction to maintenance therapy.

    The primary outcomes being measured are event-free survival, overall survival, and the cumulative incidence of relapse, evaluated at intervals of 3 years, 5 years, and 10 years after the start of the study. This trial represents a significant effort to advance the treatment of Childhood Acute Lymphoblastic Leukemia and offers hope for improved outcomes for patients affected by this condition.

    • Dexamethasone continuous
    • Dexamethasone intermittent
    • Second phase of induction
    • Standard induction therapy
    • Standard consolidation therapy
    • idarubicin
    • Methylprednisolone
    • Daunorubicin
    • Dexamethasone
    • Bortezomib