Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse Large B Cell Lymphoma
Radio-GLO
Sponsor study identifier
interventional
40
1 country
5
Study Start
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 20, 2026
Actual (reported)June 8, 2026
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Complete Response Rate After Radiotherapy and Glofitamab Treatment
The study will assess how many participants achieve a complete metabolic response after radiotherapy and 12 cycles of glofitamab treatment, without severe side effects that require stopping treatment early
37 weeks
Safety assessment through adverse events
5 years total
Assessment of impact of side effects on patient's quality of life - EORTC-QLQ-C30
5 years
Overall Toxicity (all grades)
5 years
Overall Response Rate to study treatment
5 years
Time to Treatment failure
5 years
Blood markers linked to treatment response and side effects
5 years
Gut bacteria changes linked to treatment response and side effects
5 years
Advanced PET scan measures
12 months
Radiotherapy will be delivered at 25Gy in 5 fractions to all PET/CT-avid nodal, and selected extranodal disease sites \>1.5cm diameter. Following RT, patients will commence systemic therapy and receive one dose of 1000mg obinutuzumab (IV) followed by an initial step-up dose ramp of glofitamab on day 15 and day 22 (D15 2.5mg IV, D22 10mg IV), then 30mg intravenously every 3 weeks for cycles 2-12. Participants will have FDG PET/CT scans at the start of the study, after cycles 2, 4/5 and 8/9, at the end of treatment after cycle 12, and again if the disease returns (where possible). For up to 6 patients at approved sites, an additional PET sub-study will involve two extra scans using each tracer, one before treatment starts and one after cycle 2. After finishing treatment, participants will attend follow-up clinic visits every 3 months during the first year, and then every 6 months from years 2 to 5.
Glofitamab is the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more prior systemic therapies.
25 Gy in 5 fractions.
Townsville University Hospital
Douglas, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
First Submitted
May 20, 2026
First Posted
June 8, 2026
Study Start
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 2031
EstimatedObinutuzumab as a pre-treatment to reduce the risk of CRS induced by glofitamab is approved in Australia.
89Zr-Df-crefmirlimab infusion and imaging (24hrs+/- 4 hours) - must be at least 5 days prior to the first fraction of radiotherapy of study treatment, A second infusion of 89Zr-Df-crefmirlimab and imaging will be after Cycle 2 (15 days +/- 3 days)
Eligible participants will receive an initial injection of 18F-CSB-321 followed by PET imaging up to 14 days prior to commencing therapy. 370 MBq (±10%) of 18F-CSB-321 is injected, without the need of pre-medications. Participants will be monitored for adverse events up to 2 hours post-injection.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Austin Hospital
Heidelberg, Victoria, 3084, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 8, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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