Title: 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
Study Chair: Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute, Boston, Massachusetts
Description: Researchers are seeking to assess the side effects associated with treatment with inotuzumab ozogamicin in a partially randomized phase 3 trial. In particular, the trial is studying how well inotuzumab ozogamicin works in combination with frontline chemotherapy for patients with newly diagnosed B-cell acute lymphoblastic leukemia (ALL).
Patients in one arm of the study will receive frontline chemotherapy while patients in the experimental arm of the trial will receive intravenous inotuzumab ozogamicin on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity and is given in combination with frontline chemotherapy.
The trial’s primary outcome measure is event-free survival. The trial’s secondary outcome measures include disease-free survival, overall survival, and complete response.
In order to enroll, patients must be newly diagnosed with CD-22 positive B-cell ALL. Patients cannot have received any prior therapy except for limited corticosteroid or hydroxyurea treatment (less than 7 days). To view a complete list of inclusion and exclusion criteria please refer to the reference.
This study is sponsored by Alliance for Clinical Trials in Oncology.
Clinicaltrials.gov. Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia. NCT03150693. Accessed June 16, 2021.