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Inotuzumab ozogamicin plus chemotherapy in pediatric B-ALL: ITCC-059 trial
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 0.8–1.8 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.
Results1
- 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)
Safety1
- 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)
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