A phase I trial of inotuzumab ozogamicin in combination with temsirolimus in patients with relapsed or refractory CD22-positive B-cell non-Hodgkin lymphomas. Issue 1 (2nd January 2022)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Leukemia & lymphoma. Volume 63:Issue 1(2022)
• Page Start: 117
• Page End: 123
• Publication Date: 2022-01-02
• Subjects: Phase I trial -- inotuzumab ozogamicin -- temsirolimus -- non-Hodgkin lymphomas; Leukemia -- Periodicals; Lymphomas -- Periodicals; 616.99419
• DOI: 10.1080/10428194.2021.1966780
• Languages: English
• ISSNs: 1042-8194

Abstract

Abstract: 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/m 2 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).