Sinusoidal obstruction syndrome in children with B-acute lymphoblastic leukemia (B-ALL) treated with inotuzumab ozogamicin: Results from the ITCC-059 trial - Scorecard - 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

  • 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

  • August 21, 2026

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Clinical Scorecard: Sinusoidal Obstruction Syndrome in Pediatric Patients with B-acute Lymphoblastic Leukemia Treated with Inotuzumab Ozogamicin: Findings from the ITCC-059 Study

At a Glance

CategoryDetail
ConditionSinusoidal Obstruction Syndrome (SOS)
Key MechanismsInotuzumab ozogamicin (InO) may cause endothelial injury through local release of calicheamicin by malignant CD22-positive blasts and direct toxicity via Fcγ receptor-mediated endocytosis.
Target PopulationPediatric patients with relapsed or refractory B-acute lymphoblastic leukemia (B-ALL)
Care SettingClinical trial setting (ITCC-059 study)

Key Highlights

  • SOS developed in 15% of pediatric patients receiving InO.
  • Complete resolution of SOS occurred in 72% of affected patients.
  • The sole significant predictor of SOS was a shorter interval between InO and HSCT.
  • Overall survival at 1 year was 57% for the entire cohort.
  • Post-transplant non-relapse mortality was 20% among patients undergoing HSCT within 6 months after InO.

Guideline-Based Recommendations

Diagnosis

  • Monitor for SOS in pediatric patients receiving InO, especially prior to HSCT.

Management

  • Consider defibrotide prophylaxis in patients at risk for SOS.

Monitoring & Follow-up

  • Assess liver function and clinical signs of SOS during and after InO treatment.

Risks

  • Increased risk of SOS associated with HSCT performed within 35 days of the last InO dose.

Patient & Prescribing Data

Pediatric patients aged ≥ 1 year with R/R CD22-positive B-ALL.

InO is used for reinduction or as a bridge to HSCT, with careful monitoring for SOS.

Clinical Best Practices

  • Evaluate the timing of HSCT relative to InO administration to mitigate SOS risk.
  • Utilize risk-factor analysis to identify patients at higher risk for SOS.

Related Resources & Content

Original Source(s)

Sinusoidal obstruction syndrome in children with B-acute lymphoblastic leukemia (B-ALL) treated with inotuzumab ozogamicin: Results from the ITCC-059 trial

  • 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

  • August 21, 2026

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