Sinusoidal obstruction syndrome in children with B-acute lymphoblastic leukemia (B-ALL) treated with inotuzumab ozogamicin: Results from the ITCC-059 trial - Report - 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
Clinical Report: Sinusoidal Obstruction Syndrome in Pediatric Patients with B-ALL
Overview
The ITCC-059 study evaluated the incidence of sinusoidal obstruction syndrome (SOS) in pediatric patients with relapsed or refractory B-acute lymphoblastic leukemia treated with inotuzumab ozogamicin. Among 120 participants, SOS developed in 15% of patients, with notable outcomes following hematopoietic stem cell transplantation.
Background
Sinusoidal obstruction syndrome (SOS) is a significant safety concern in pediatric patients receiving inotuzumab ozogamicin, particularly around the time of hematopoietic stem cell transplantation (HSCT). The ITCC-059 study provides insights into the safety profile of inotuzumab ozogamicin in this context.
Data Highlights
Parameter
Value
Total Patients
120
Patients with SOS
18 (15%)
Post-HSCT SOS Cases
14
Complete Resolution of SOS
13 (72%)
Deaths due to SOS
5 (28%)
Key Findings
Among 120 pediatric patients, SOS developed in 18 (15%) of cases.
Four SOS cases occurred without HSCT, while 14 were diagnosed post-HSCT.
Complete resolution of SOS was observed in 72% of affected patients.
The sole statistically significant predictor of SOS was a shorter interval between the final InO dose and HSCT.
Patients undergoing HSCT within 35 days of the last InO dose had a higher SOS risk (OR 3.6).
Clinical Implications
Clinicians should be vigilant for the development of SOS in pediatric patients receiving inotuzumab ozogamicin, especially those undergoing HSCT shortly after treatment.
Conclusion
The findings from the ITCC-059 study highlight the incidence of SOS in pediatric patients treated with inotuzumab ozogamicin.
Related Resources & Content
Kumar, A., et al., The ASCO Post, 2024 -- Inotuzumab Ozogamicin for Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia
Smith, J., et al., The ASCO Post, 2024 -- Inotuzumab Ozogamicin for Pediatric Acute Lymphoblastic Leukemia
The ASCO Post, 2026 -- Inotuzumab Ozogamicin Induces Long-Term Survival in B-Cell ALL
The ASCO Post, 2024 -- FDA Approves Inotuzumab Ozogamicin for Pediatric Patients With ALL
Inotuzumab ozogamicin in paediatric very high risk first B-cell acute lymphoblastic leukaemia relapse (ITCC-059): a multicentre, single-arm, phase 2 trial - PubMed
Allogeneic HSCT outcomes and impact of defibrotide prophylaxis on SOS after inotuzumab in pediatric B-ALL - PubMed
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
