Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia
Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
This trial is a limited multi-center, Phase II study to evaluate inotuzumab ozogamicin
(Besponsa) in pediatric patients with MRD positive CD22-positive B-lymphoblastic leukemia
(B-ALL).
Some patients with newly diagnosed ALL maintain low levels of MRD, despite achieving complete
remission with less than 5% blasts in the bone marrow. Others experience re-emergence of low
level MRD or increasing levels of MRD on therapy or post-transplant. New approaches are
needed to achieve undetectable MRD in these high-risk patients.
Inotuzumab ozogamicin is an antibody-drug conjugate composed of a humanized IgG subtype 4
monoclonal CD22-targeted antibody linked to calicheamicin, a potent anti-tumor antibiotic.
CD22 is expressed in more than 90% of patients with B-cell ALL, making it an attractive
target in this patient population. Inotuzumab ozogamicin has demonstrated exceptional
activity in adults with relapsed or refractory B-ALL.
Primary Objective
- Assess the efficacy of inotuzumab ozogamicin in patients with MRD positive CD22+ B-ALL
with 0.1 - 4.99% blasts in bone marrow.
Secondary Objectives
- Study the safety of inotuzumab ozogamicin when used in patients with MRD - positive
CD22+ B-ALL with < 5 % blasts in bone marrow.
- 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).