[NCI CIRB] A041501 - 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
This study is to test the safety of adding inotuzumab to usual chemotherapy regimen in young adults with newly diagnosed precursor B-Cell ALL. The second portion of the study is to test the effects, and event free survival, of using inotuzumab with the usual chemotherapy compared to the usual treatment alone.
Newly Diagnosed precursor B-Cell ALL
Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible.
No prior treatment for ALL except for corticosteriods, hydroxyurea, single dose intrathecal cytarabine
Between the ages of 18 and 40 years of age
Not pregnant or nursing
Performance status between 0-2
Patients with Down Syndrome are excluded due to likelihood of excessive toxicity
Lab values within range per protocol
18 - 40
Healthy Volunteers Needed
Duration of Participation
10 years from study entry
Knight Cancer Institute Clinical Trials