Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse Large B Cell Lymphoma
brief summary
The goal of this clinical trial is to see if a new combination of standard of care radiotherapy treatment prior to administering the study drugs obinutuzumab and glofitamab in relapsed/refractory Diffuse Large B Cell Lymphoma patients is effective. The main question it aims to answer is: If you are able to tolerate the study treatments, and whether your cancer responds to the study treatment, compared with other reported studies of standard care treatments. Participants will have three parts they need to complete over a 5 year period. * Screening period over a 28 day period * Treatment period - Radiotherapy followed by 12 treatment cycles every three weeks (total time approx. 37 weeks) * Follow up, up to 4 years. Additional PET imaging studies will be performed in a cohort of patients (up to 6) who are willing to undergo infusions of 89Zr-Df-Crefmirlimab and 18F-Granzyme B for evaluation of the impact of radiotherapy plus glofitamab with relapsed diffuse large B-cell lymphoma.
detailed description
Clinical trial looking at Radiotherapy in combination with glofitimab in relapsed/refractory Diffuse Large B Cell lymphoma. Where Relapsed/refractory diffuse large B-cell lymphoma after ≥ 2 therapies OR after 1 line AND transplant or CAR-T ineligible. The primary end points is to see what proportion of patients who achieve a complete metabolic response in the absence of prohibitive toxicity following radiotherapy (25Gy in 5 fractions) plus 12 cycles of glofitamab therapy with each cycle delivered every 3 weeks. The secondary endpoints are to assess overall toxicity, to evaluate overall response rates, duration of Response (DOR), time to treatment failure, progression free survival, overall survival, patient report outcome measure - Using EORTC QLD-C30, EORTC IL46 and PRO-CTCAE.
Additional PET imaging studies will be performed in a cohort of patients (up to 6) who are willing to undergo infusions of 89Zr-Df-Crefmirlimab and for evaluation of the impact of radiotherapy plus glofitamab on CD8+ T cell biodistribution in the body and in relapsed diffuse large B-cell lymphoma.
Additional PET imaging studies will be performed in a cohort of patients (up to 6) who are willing to undergo infusions of 18F-Granzyme B to image active immune responses to treatment with radiotherapy plus glofitamab in patients with relapsed diffuse large B-cell lymphoma.
official title
Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse Large B Cell Lymphoma: The Phase II Radio-GLO Study