This phase II trial studies how well inotuzumab ozogamicin works in treating patients with minimal residual disease (MRD) positive CD22 positive (+) B cell acute lymphoblastic lymphoma that has come back. Minimal residual disease is when there is evidence for remaining tumor following initial treatment that is only apparent using highly sensitive techniques, but there are no other signs of leukemia in the bone marrow or blood yet. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22+ cancer cells in a targeted way and delivers ozogamicin to kill them.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03913559.
PRIMARY OBJECTIVES:
I. Assess the efficacy of inotuzumab ozogamicin in patients with MRD positive CD22+ B acute lymphoblastic lymphoma (B-ALL) with 0.1 - 4.99% blasts in bone marrow.
SECONDARY OBJECTIVES:
I. Study the safety of inotuzumab ozogamicin when used in patients with MRD positive CD22+ B-ALL with < 5 % blasts in bone marrow.
II. Estimate the incidence, severity, and outcome of hepatotoxicity and sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) in patients during inotuzumab ozogamicin and following subsequent treatment, including hematopoietic stem cell transplant (HSCT).
OUTLINE:
Patients receive inotuzumab ozogamicin intravenously (IV) over 60 minutes on days 1, 8, and 15. Patients also receive methotrexate intrathecally (IT), hydrocortisone sodium succinate IT, and cytarabine IT weekly or every 2 weeks. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year.
Lead OrganizationSaint Jude Children's Research Hospital
Principal InvestigatorSima C. Jeha