Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

Launched by ST. ANNA KINDERKREBSFORSCHUNG · Sep 19, 2013

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a treatment called allogeneic stem cell transplantation (HSCT) for children and adolescents with a type of cancer known as Acute Lymphoblastic Leukemia (ALL). The goal is to see how well this treatment works in young patients who are in complete remission, meaning their cancer is not currently detectable. The study also aims to optimize the treatment process, ensuring that the best care is provided based on each patient’s unique needs and the availability of a suitable donor for the stem cells.

To participate in this trial, patients need to be diagnosed with ALL (not B-ALL), be between the ages of 30 days and 21 years, and must be in complete remission before receiving the stem cell transplant. It's important that parents or guardians provide written consent for their child to join the study. Participants will be treated in specialized centers that are part of the study. If accepted, families can expect a carefully monitored treatment process tailored to their child’s condition, with the aim of improving outcomes for young patients facing this challenging disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients with ALL (except for patients with B-ALL) who fulfil the following criteria:
• • age at diagnosis ≤ 18 years. Age at HSCT ≤ 21 years
• • indication for allogeneic HSCT
• • complete remission (CR) before HSCT
• • written consent of the parents (legal guardian) and, if necessary, the minor patient via "Informed Consent Form"
• • no pregnancy
• • no secondary malignancy
• • no previous HSCT
• • HSCT is performed in a study participating centre
• Exclusion Criteria:
• • patients who do not fulfil the inclusion criteria
• • Non Hodgkin-Lymphoma
• • the whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
• • no consent is given for saving and propagation of anonymous medical data for study reasons
• • severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
• • Karnofsky / Lansky score \< 50%
• • subjects unwilling or unable to comply with the study procedures