Trial Number

001-19

Age range

1 year to 25 years

Gender

Male or Female

Enrolling Patients

Yes

With advances in risk-stratification for patients with B-ALL, overall outcomes have improved remarkably in recent decades with current survival rates of approximately 90%. However, certain subgroups have inferior outcomes, including those with adverse genetic lesions or slow response to initial therapy. For these patients, intensification of classic conventional chemotherapeutic agents has proven too toxic or has failed to improve survival rates. In contrast, targeted immunotherapies demonstrate impressive response rates in heavily pre-treated populations and may lead to higher cure rates without excessive toxicity. InO is an antibody drug conjugate (ADC) composed of a humanized IgG monoclonal CD22-targeted antibody linked to calicheamicin, a potent antitumor antibiotic. The purpose of this phase 2 study is to determine, in a randomized manner, if the addition of 2 blocks of inotuzumab ozogamicin to modified Berlin-Frankfurt-Münster (mBFM) chemotherapy will improve 5-year disease-free survival (DFS) in children and young adults with High-Risk (HR) B-cell acute lymphoblastic leukemia (B-ALL).

Principal Investigator

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