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B-Cell Acute Lymphoblastic Leukemia: Adding Inotuzumab Ozogamicin to Chemotherapy

Research Question:
Does adding inotuzumab ozogamicin to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improve outcomes?

Basic Study Information

Purpose:
Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab.

Location: University of Rochester Medical Center
Study Reference #: PLEU19175

Lead Researcher (Principal Investigator)

Lead Researcher: Angela Girvin

Study Contact Information

Study Coordinator: Haley Misch
Phone: (585) 275-9485
Email: Haley_Misch@URMC.Rochester.edu

Additional Study Details

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