All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know ALL.

The ALL Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy


Now you can personalise
your ALL Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more

The ALL Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the ALL Hub cannot guarantee the accuracy of translated content. The ALL Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact
You're logged in! Click here any time to manage your account or log out.
You're logged in! Click here any time to manage your account or log out.

Inotuzumab ozogamicin plus chemotherapy in pediatric B-ALL: ITCC-059 trial

Feb 9, 2024
Learning objective: After reading this article, learners will be able to cite a new clinical development in ALL

Bookmark this article

The ALL Hub has previously reported results from the phase II ITCC-059 study (EudraCT:2016-000227-71), outlining the safety and efficacy of inotuzumab ozogamicin (InO) as a single agent in pediatric patients with relapsed/refractory B-cell lineage acute lymphoblastic leukemia.

Here, we summarize results from the phase Ib analyses of the ITCC-059 trial investigating InO combined with chemotherapy, published by Pennesi et al.1 in Haematologica.

Study design1

  • InO (dose 0.81.8 mg/m2) was coupled with intrathecal treatment, 20 mg/m2 of dexamethasone (two 5-day blocks, subsequently modified), and 1.5 mg/m2 of vincristine (Days 3, 10, 17, 24); 29 patients were evaluated for dose-limiting toxicities (DLTs) between May 2020 and April 2022.


  • Two out of four patients experienced DLT (liver toxicity) at 1.1 mg/m2/cycle
    • InO dosage was deescalated to 0.8 mg/m2/cycle (n = 6) without DLT while a protocol amendment to lower the dexamethasone dose to 10 mg/m2 was awaited
    • InO was reescalated to 1.1 mg/m2/cycle (n = 6, 1 DLT) following the amendment; this was followed by 1.4 mg/m2/cycle (n = 3, no DLTs), and 1.8 mg/m2/cycle (n = 7, 1 DLT)
  • In total, 24 patients achieved a complete response (overall response rate, 80%), with 22 achieving it after the first cycle with 20 in CR, three in CR with insufficient platelet recovery, and one in complete remission with incomplete blood count recovery
  • In total, 66.7% of respondents met the measurable residual disease negativity threshold
  • In a fractionated regimen, the recommended phase II dose of InO in combination with vincristine, dexamethasone, and intrathecal treatment was established at 1.8 mg/m2/cycle (1.5 mg/m2/cycle after remission)


  • Overall, 24 patients had either aspartate aminotransferase and/or alanine aminotransferase elevation
    • Alanine aminotransferase increased in 23 patients (50% were ≥Grade 3)
    • Aspartate aminotransferase increased in 22 patients; 10 were Grade 3 (33.3%)
    • Seven patients (23.3%) had a bilirubin increase (20% were Grade 1–2 and 3% were Grade 3)
Key learnings
  • While liver toxicity was present at the initial higher dose of dexamethasone, the combination of InO plus chemotherapy demonstrated a response rate comparable with the single-agent cohorts in this trial
  • The combination of InO at a dose up to 1.8 mg/m2 with vincristine, dexamethasone, and intrathecal treatment is safe and efficacious

  1. Pennesi E, Brivio E, Ammerlaan ACJ, et al. Inotuzumab ozogamicin combined with chemotherapy in pediatric B-cell precursor CD22+ acute lymphoblastic leukemia: results of the phase IB ITCC-059 trial. Haematologica. 2024. Published online ahead of print. DOI: 3324/haematol.2023.284409


Subscribe to get the best content related to ALL delivered to your inbox