Publikation

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

Wissenschaftlicher Artikel/Review - 19.08.2021

Bereiche
PubMed
DOI
Kontakt

Zitation
Pirosa M, Zhang L, Hitz F, Novak U, Hess D, Terrot T, Pascale M, Mazzucchelli L, Bertoni F, Cavalli F, Zucca E, Stathis A. A phase I trial of inotuzumab ozogamicin in combination with temsirolimus in patients with relapsed or refractory CD22-positive B-cell non-Hodgkin lymphomas. Leuk Lymphoma 2021; 63:117-123.
Art
Wissenschaftlicher Artikel/Review (Englisch)
Zeitschrift
Leuk Lymphoma 2021; 63
Veröffentlichungsdatum
19.08.2021
eISSN (Online)
1029-2403
Seiten
117-123
Kurzbeschreibung/Zielsetzung

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 ( = 8), neutropenia ( = 5), and two patients each hyperphosphatemia, lymphopenia, and hypertriglyceridemia. The recommended phase II dose was inotuzumab ozogamicin 0.8 mg/m 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).