Acute Lymphoblastic Leukemia Treatment with Inotuzumab Ozogamicin as part of Chemotherapy – Phase III

AALL1732: A Study to Test if the Addition of Inotuzumab Ozogamicin to Standard Chemotherapy Treatment Improves Outcomes for Patients Diagnosed with National Cancer Institute High-Risk B-cell Acute Lymphoblastic Leukemia, or Standard-Risk B-cell Acute Lymphoblastic Leukemia with High-Risk Features

Protocol Description

Through this multi-center Children’s Oncology Group study, researchers are investigating how well inotuzumab ozogamicin works in combination with standard chemotherapy in treating patients diagnosed with high-risk (HR) B-cell acute lymphoblastic leukemia (B-ALL), or Standard-Risk (SR) B-ALL with HR aspects, both conditions as defined by the National Cancer Institute (NCI).

Study Level: III

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling pediatric patients who have NCI HR B-ALL or NCI SR B-ALL with certain high-risk aspects.
Males and Females: Ages 1 through 24 years


The first phases of the trial, called the induction and consolidations phases, last 5 and 8 weeks, respectively, and provide non-experimental chemotherapy drugs along with testing to determine participants’ eligibility to remain in the study through the phase that introduces inotuzumab ozogamicin as part of the therapeutic regimen. This latter phase of the study includes chemotherapy, testing and physical examinations.
Visits: Number of visits will vary based on participant response to therapy.
Duration: About 2 years for therapy in most cases, followed by 10 years of long-term follow-up.

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (AALL1732)
National Cancer Institute

Primary Investigator

A. Kim Ritchey, MD

Contact Information

For more information about the study or enrollment, please contact the UPMC Children’s Hospital of Pittsburgh Hematology-Oncology research team, at: