About the Study

B-Cell Acute Lymphoblastic Leukemia (B-ALL): A clinical trial to study inotuzumab ozogamicin (InO) in combination with chemotherapy in children and young adults with relapsed or refractory B-ALL

This study is for: • Patients who are between the ages of 1 year and 22 years old • Who have been diagnosed with B-lymphoblastic leukemia (B-ALL) that is refractory (has not responded to earlier treatment) or is in second or greater relapse (has come back) • The ALL also must have a specific protein present called CD22 The overall goal of this study is to find out what effect, good and/or bad, the study drug inotuzumab ozogamicin (InO) in combination with chemotherapy has on children and young adults with relapsed or refractory B-ALL. The treatment used in this study involves cancer fighting medicine called chemotherapy plus the medicine InO. The treatment on this study takes about 2 months, divided into 2 phases of therapy.

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Full Study Name: AALL1621 - A Phase 2 Study of Inotuzumab Ozogamicin in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)