Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy

To compare in a randomized manner the 5-year disease-free survival for children and young adults with High Risk B-cell acute lymphoblastic leukemia treated with modified Berlin-Frankfurt-Munster chemotherapy without delayed intensification part 2, but with the addition of two blocks of inotuzumab ozogamicin, versus those treated with full Berlin-Frankfurt-Munster chemotherapy backbone including delayed intensification part 2 without the addition of inotuzumab ozogamicin

• Children and Adults 1-24 years of age
• Must be enrolled on APEC14B1
• Newly diagnosed B-cell Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia with > 25% blasts on a bone marrow aspirate OR If a bone marrow aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a bone marrow biopsy OR have a complete blood count of at least 1,000/uL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed
• Newly diagnosed B-cell Lymphoblastic Lymphoma Murphy stages III or IV
• Newly diagnosed B-cell Lymphoblastic Lymphoma Murphy stages I or II with steroid pretreatment

• Standard chemotherapy based on age and white blood cell count (standard-risk group), or
• Inotuzumab ozogamicin in addition to chemotherapy (high-risk group), or
• More intensive therapy and possible stem cell transplant (very high-risk group)