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

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 (2022). A phase I trial of inotuzumab ozogamicin in combination with temsirolimus in patients with relapsed or refractory CD22-positive B-cell non-Hodgkin lymphomas. Leukemia & lymphoma, 63(1), pp. 117-123. Taylor & Francis 10.1080/10428194.2021.1966780

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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).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Medical Oncology

UniBE Contributor:

Novak, Urban

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1029-2403

Publisher:

Taylor & Francis

Language:

English

Submitter:

Rebeka Gerber

Date Deposited:

07 Oct 2021 11:09

Last Modified:

05 Dec 2022 15:53

Publisher DOI:

10.1080/10428194.2021.1966780

PubMed ID:

34407735

Uncontrolled Keywords:

Phase I trial inotuzumab ozogamicin non-Hodgkin lymphomas temsirolimus

URI:

https://boris.unibe.ch/id/eprint/159549

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