Inotuzumab Ozogamicin/Chemo in B Acute Lymphoblastic Leukemia

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

October 23, 2018

  • Clinical Trial Information

    Trial Contact: Donaldson, Karin M; Valdez, Crystal

    Trial Phone: 321.841.9821 ; 321.841.6626

  • IRB No: A041501

    Protocol Abbrev: A041501

    Principal Investigator: Jose E. Sarriera, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: A041501

    Treatment: Inotuzumab ozogamicin given with frontline chemotherapy vs frontline chemotherapy alone

    Therapies Involved: Medication; Oncology: 1st line

    ClinicalTrials.gov ID: NCT03150693

  • Objective

    To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, without censoring for transplant.

  • Key Eligibility

    Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible