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

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

Requirements

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

Additional Information

Study Description at the National Institutes of Health
Cancer and Blood Disorder Research 
Leukemia Overview and Causes

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:
HOCHPPhaseI-II@upmc.edu.