A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL

Protocol No
ALLIANCE-A041501-ALL
Staff Member
Guru Subramanian Guru Murthy
Phase
III
Summary

The first purpose of this study is to test the safety of the addition of a new drug called inotuzumab along with the usual chemotherapy drugs used for adolescent young adults. Inotuzumab is investigational and is not FDA-approved. There will be about 6 to 12 patients taking part in this first portion of the study.

The second purpose of this study is to compare any good and bad effects of using inotuzumab along with the usual chemotherapy treatment for ALL cancer to using the usual treatment alone. The addition of inotuzumab to the usual treatment could prevent the cancer from returning or getting worse but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. There will be about 324 people taking part in this study.

Objective
Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia
Study Sites
Froedtert Hospital
Status
OPEN TO ACCRUAL