Finding studies
Finding studies
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Lead
Australasian Leukaemia and Lymphoma Group
The goal of this clinical trial is to evaluate the safety and response of combination Pirtobrutinib and Glofitimab in patients with relapsed/refractory MCL. The main question it aims to answer are: * Will additive and synergistic effects be observed when using a combination of glofitamab and pirtobrutinib? * Will this combination be safe and lead to high complete- and MRD-negative remission rates? Participants will receive treatment based on 21 day cycles. This study design involves 3 phases: 1. Treatment Ramp-Up 1. Pre-Phase (7 days): Obinutuzumab (1000mg) will be administered intravenously (IV) on D-7 and a second dose administered between Day 6 and Day 1. 2. Cycle 1: An initial dose level of Glofitamab will evaluate step-up dosing. If excessive dose-limiting toxicity is observed, including cytokine release syndrome (CRS), a lower initial dose of 1.25mg of glofitamab will be evaluated at "dose level -1". i. Dose level 1 (14 days): * 2.5mg Glofitamab by IV on Day 1 * 10mg Glofitamab by IV on Day 8 ii. Dose level -1 (21 days): * 1.25mg Glofitamab by IV on Day 2 * 2.5mg Glofitamab by IV on Day 8 * 10mg Glofitamab by IV on Day 15 c. Cycle 2 (21 days): 30mg Glofitamab by IV on Day 1 2. Fixed course combination phase: Cycles 3-12 (21 days per cycle): 30mg of Glofitamab by IV on day 1 3. Maintenance phase: Cycles 13+ (21 days per cycle): Glofitamab discontinued. 200mg oral daily
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
