Use the hyperlinks, where available to access additional clinical trial information.
A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy
Children's Oncology Group
Other Non-Commercial Sponsor
National Cancer Institute (NCI)
The overall goal of this randomised, open-label study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukaemia. The first part of the study has two phases of therapy: Induction and Consolidation. This part will collect information on the leukaemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. In the second part of the study, patients will receive the remainder of the chemotherapy cycles with some patients randomised to receive inotuzumab. Other aims of the study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukaemia (B LLy) or Mixed Phenotype Acute Leukaemia (MPAL) when treated with B-ALL chemotherapy.