Growth retardation with nilotinib treatment in pediatric patients with Ph+ CML

Key clinical point: Long-term analysis indicated clear growth deceleration over time during nilotinib treatment in pediatric patients with newly diagnosed or imatinib/dasatinib resistant/intolerant Philadelphia chromosome-positive (Ph⁺) chronic myeloid leukemia (CML).

Major finding: Overall median change in height standard deviation scores after 48 cycles of nilotinib treatment vs baseline was −0.54 (range, −1.6 to 0.4) in patients resistant/intolerant to imatinib or dasatinib and −0.91 (range, −1.4 to −0.1) in patients with newly diagnosed CML. No new safety concerns were reported.

Study details: Findings are from the phase 2 DIALOG study including 58 pediatric patients with newly diagnosed (n=25) or imatinib or dasatinib resistant/intolerant (n=33) Ph⁺ CML who received at least 48 cycles of nilotinib treatment or discontinued the study.

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Disclosures: This study was sponsored and funded by Novartis Pharmaceuticals Corporation. Some investigators including the lead author reported ties with Novartis.

Source: Hijiya N et al. Blood Adv. 2021 Jul 26. doi: 10.1182/bloodadvances.2020003759.