Participants in this research study have Acute Lymphoblastic Leukemia that is either:
- Relapsed: This means that the participant had a response to his/her most recent treatment, but the cancer came back.
- Refractory: This means that the participant did not have any response or his/her disease got worse while receiving the most recent treatment.
The main purpose of this research study is to learn if inotuzumab ozogamicin is a more effective treatment when compared to some chemotherapy regimens used in patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL). This study will also look at the side effects associated with inotuzumab ozogamicin treatment and how participants’ bodies distribute inotuzumab ozogamicin. Inotuzumab ozogamicin is an “investigational drug”. This means the drug has not been approved by the U.S. Food and Drug Administration (FDA).
This study will enroll a minimum of 194 to a maximum of 292 people, unless stopped earlier. The study is being conducted globally at approximately 100 sites.