A Randomized Trial of the I-BFM-SG for the Management of Childhood non-mature-B Acute Lymphoblastic Leukemia

简要总结

主要结局

次要结局

• Time to death from any cause, measured from the time of randomization (survival time).
• End of induction (day 33) and end of early intensification (day 78) MRD status.
• Safety of rituximab in combination with intensive chemotherapy: -Death in CR will be compared between the two arms. -The rate of severe infections (CTC grade 3 to 5) during the treatment and until the end of chemotherapy will be compared between the two arms. -The rate of rituximab infusion reactions (total number and by severity of reactions) will be estimated. -The rate of intensive care unit admissions will be compared between the two arms.
• -Occurrence of infections on the target list (presumably associated with rituximab) will be compared between the two arms: cytomegalovirus, progressive multifocal leukoencephalopathy and Herpes zoster. -Need for immunoglobulin substitution will be compared between the two arms. IgG level will be measured at day 0 and then by physician discretion, but at least once monthly until the end of intensive chemotherapy and once every 3 months during maintenance chemotherapy until reaching normal level w
• Additional Researchs: -To determine the relationship between CD20 expression on ALL blasts (initially, day 15, day 33, day 78) and response to monoclonal antibody therapy. -To determine whether the administration of an anti-B cell monoclonal antibody limits the incidence of peg-asparaginase allergy occurrence.