B-Cell Acute Lymphoblastic Leukemia: Adding Inotuzumab Ozogamicin to ChemotherapyResearch 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:Location: University of Rochester Medical Center
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.
Study Reference #: PLEU19175
Lead Researcher (Principal Investigator)
Lead Researcher: Angela Girvin
Study Contact InformationStudy Coordinator: Haley Misch
Phone: (585) 275-9485
Additional Study Details
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