Combined Immuno-chemotherapy for Patients With B-linear Acute Lymphoblastic Leukemia Diagnosed From 0 to 365 Days of Life (ALL-Baby-2021)

Launched by FEDERAL RESEARCH INSTITUTE OF PEDIATRIC HEMATOLOGY, ONCOLOGY AND IMMUNOLOGY · Aug 26, 2021

Keywords

ClinConnect Summary

The ALL-Baby-2021 clinical trial is studying a new treatment approach for infants diagnosed with Acute Lymphoblastic Leukemia (ALL), a type of blood cancer. This trial aims to combine chemotherapy with immunotherapy and, for some patients, a procedure called hematopoietic stem cell transplantation (HSCT), based on the patient's risk level. Children are grouped into standard, intermediate, or high risk depending on specific genetic factors and how well they respond to initial treatment. This way, doctors can tailor treatment to better suit each child's needs, improving their chances of recovery.

To participate in this trial, infants aged 1 to 365 days who have been diagnosed with ALL can be enrolled, provided they start treatment within the study's timeframe and their diagnosis is confirmed through specific tests. Parents or guardians must give consent for their child's involvement. Throughout the trial, participants will receive closely monitored care and treatments that may include a combination of therapies designed to target their specific risk group. It's important to note that children with certain other health issues or previous treatments that might affect the study's outcomes will not be eligible. This trial is currently recruiting participants and aims to provide new insights into effective treatments for young children battling this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age at diagnosis at 1 to 365 days of life.
• • The start of induction therapy within a time interval of study recruitment phase.
• • The diagnosis of ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow (see "Diagnostics"). Patients with B-cell (Burkitt) ALL are excluded.
• • Informed consent of the patient parents (guardians) to be treated in one of the clinics included in this study.
• Exclusion Criteria:
• • The disease is a relapse of previously misdiagnosed and, therefore, inadequately treated ALL;
• • There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.);
• • There is a lack of important data needed for the exact adherence to the cytostatic therapy according to a specific chemotherapy protocol (differential diagnosis of ALL-AML (acute myeloid leukemia) is not possible, stratification according to therapeutic group is not possible);
• • The patient was treated before for a long time with cytotoxic drugs;
• • There were treatment deviations not covered by the protocol and/or not due to side effects of treatment and/or complications of the disease