Abstract
Despite the advance of treatment and biologic analyses in pediatric hematology, the quality of clinical study and its monitoring system have been low in Japan. In 1996, an intergroup collaborative study of infant leukemia was organized ; the event-free survival of infant ALL with positive MLL rearrangement has been improved with the combination of intensive chemotherapy and hematopoietic stem cell transplantation (HSCT) (MLL96/MLL98 study). The data was analyzed in a research center, and the follow-up of each patient was performed by regional investigators and the managing office. However, the variation of treatment was large among patients, because the exact follow-up system was not organized in these studies. In the next study (MLL03), therefore, all patients will use identical protocol regimens to clarify the prognostic factors in infant ALL. In addition, supporting systems by several specific committees have been organized. These systems will help us to perform high-quality clinical trials for infant ALL.
