Sinusoidal obstruction syndrome in children with B-acute lymphoblastic leukemia (B-ALL) treated with inotuzumab ozogamicin: Results from the ITCC-059 trial - Summary - MDSpire
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Sinusoidal Obstruction Syndrome in Pediatric Patients with B-acute Lymphoblastic Leukemia Treated with Inotuzumab Ozogamicin: Findings from the ITCC-059 Study
This study aimed to evaluate the incidence of sinusoidal obstruction syndrome (SOS) and identify associated risk factors in pediatric patients diagnosed with relapsed or refractory B-acute lymphoblastic leukemia (B-ALL) who were treated with inotuzumab ozogamicin (InO).
Approach:
Study Design: The ITCC-059 study was an international Phase I–II clinical trial designed to assess both the safety and therapeutic activity of InO in pediatric patients with relapsed or refractory B-ALL. The treatment was administered either as a standalone therapy or in conjunction with chemotherapy regimens.
Patient Evaluation: The study involved a cohort of 120 pediatric participants, focusing on the incidence of SOS, clinical outcomes, and potential risk factors. Detailed patient characteristics, including age, sex, disease status, and treatment history, were provided in supplementary materials to enhance the understanding of the study population.
Key Findings:
The investigation revealed a significant incidence of SOS among pediatric patients receiving InO, highlighting the need for careful monitoring in this population.
Notably, the incidence of SOS was particularly pronounced in patients who underwent hematopoietic stem cell transplantation (HSCT) following treatment with InO, indicating a possible link between the two treatment modalities.
A significant association was identified between the timing of HSCT and the administration of InO, suggesting that the sequence of these treatments may influence the risk of developing SOS. This finding underscores the importance of treatment planning and timing in managing pediatric patients with B-ALL.
Interpretation:
The findings from the ITCC-059 study indicate a notable incidence of SOS in pediatric patients treated with InO, especially in those who received HSCT afterward. The significant association between the timing of HSCT and InO administration suggests that careful consideration of treatment sequencing may be critical in mitigating the risk of SOS.
Limitations:
The relatively small number of patients evaluated in the study may limit the generalizability of the findings to the broader pediatric population with B-ALL.
Additional research is warranted to further elucidate the underlying mechanisms contributing to SOS and to identify further risk factors that may affect this population.
Conclusion:
SOS occurred in 15% of patients, predominantly after HSCT.
by Angela Iannicelli, Franco Locatelli, Yilin Jiang, Anneke Ammerlaan, Susana Rives, Inge M. van der Sluis, Caroline Lindemans, Bella Bielorai, Cristina Díaz de Heredia, Andrej Lissat, Claudia Rossig, Arnaud Petit, Fanny Rialland Battisti, Carmelo Rizzari, Anna B. Nilsson, Benedicte Bruno, Alba Rubio San Simón, Lucie Sramkova, Gernot Engstler, Uta Dirksen, Benoit Brethon, Barbara De Moerloose, Marlène Pasquet, Peter McCarthy, Karsten Nysom, Carine Halfon-Domenech, Nicoletta Bertorello, Jochen Buechner, Peter Bader, C. Michel Zwaan, Erica Brivio
