A phase I trial of inotuzumab ozogamicin in combination with temsirolimus in patients with relapsed or refractory CD22-positive B-cell non-Hodgkin lymphomas.

Autor: Pirosa, Maria C., Zhang, Lu, Hitz, Felicitas, Novak, Urban, Hess, Dagmar, Terrot, Tatiana, Pascale, Mariarosa, Mazzucchelli, Luca, Bertoni, Francesco, Cavalli, Franco, Zucca, Emanuele, Stathis, Anastasios
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Zdroj: Leukemia & Lymphoma; Jan2022, Vol. 63 Issue 1, p117-123, 7p
Abstrakt: This phase I trial evaluated the safety, tolerability, and preliminary activity of inotuzumab ozogamicin in combination with temsirolimus in patients with relapsed/refractory CD22 positive B-cell non-Hodgkin lymphomas. Nineteen patients received at least one dose of both study drugs. Dose-limiting toxicities consisted of thrombocytopenia, hypertriglyceridemia, oral mucositis, clinical deterioration, and the inability to receive at least three doses of temsirolimus during cycle 1. The most common grade ≥3 treatment-related adverse events were thrombocytopenia (n = 8), neutropenia (n = 5), and two patients each hyperphosphatemia, lymphopenia, and hypertriglyceridemia. The recommended phase II dose was inotuzumab ozogamicin 0.8 mg/m2 on day 1 in combination with temsirolimus 10 mg on days 8, 15, and 22 every 28 days. Among 18 patients evaluable, seven (39%) with follicular lymphoma had a partial remission. This drug combination is not possible within a therapeutically useful range of doses due to toxicities. Antitumor activity was observed in heavily pretreated patients (ClinicalTrials.gov, Identifier NCT01535989). [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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