Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse Large B Cell Lymphoma (NCT07634289) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse Large B Cell Lymphoma
Australia40 participantsStarted 2026-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 years.
. Histologically proven relapsed/refractory CD20+ve DLBCL or a recognised subtype, including follicular large B-cell lymphoma and high grade B-cell lymphoma.
. Prior systemic treatment: ≥2 lines OR after 1 line AND autologous stem cell transplant/CAR-T ineligible
. Eastern Collaborative Oncology Group (ECOG) performance status 0 to 2.
. Measurable FDG avid disease on baseline PET/CT scan
. At least one site of active, PET positive disease that can be safely irradiated. Patients with disease only in previously irradiated sites that cannot be safely irradiated again due to tissue tolerance will be excluded.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines radiotherapy with glofitamab for relapsed or refractory DLBCL — given that my specific situation involves relapsed or refractory disease, does my doctor think this combination approach makes sense as a next step compared to other options I might have right now?
2Since this is a Phase 2 trial and it's not yet recruiting, what does that mean for how much is already known about the safety of combining glofitamab with radiotherapy, and what risks should I be aware of that earlier studies may have flagged?
3The trial is measuring complete response rate as its main goal — can my doctor explain what achieving a complete response would mean for my long-term outlook, and how the response rates seen so far with glofitamab alone compare to what this combination is hoping to achieve?
4Because this trial isn't recruiting yet, how long might I realistically have to wait before I could even be considered for enrollment, and is that waiting period safe given where my disease stands today?
5Are there currently available standard treatments or other open clinical trials for relapsed or refractory DLBCL that I should try first, or that might be a better fit for me while I wait for this study to open?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete Response Rate After Radiotherapy and Glofitamab Treatment
Timeframe: 37 weeks
Trial details
NCT IDNCT07634289
SponsorOlivia Newton-John Cancer Research Institute
. Adequate renal function with serum creatinine ≤1.5 x ULN or creatinine clearance (CrCl) ≥ 45mL/min (using Cockcroft-Gault formula, Modification of Diet in Renal Disease Study Equation, 24hr urine collection, eGFR or a formal nuclear medicine technique) unless attributed to lymphoma (e.g. ureteric obstruction).
Exclusion criteria
. Patient has failed only one prior line of therapy and is a candidate for stem cell
. Transplantation or CAR-T cell therapy
. Excessively bulky or rapidly progressive disease that, in the opinion of the investigator, requires rapid debulking or is unsafe to be irradiated
. Richter's transformation from CLL. Transformation from other low-grade histology (e.g. Follicular lymphoma, Marginal zone lymphoma etc) is permitted
. Refractory to prior therapy with glofitamab or other anti-CD3/CD20 bispecific antibodies, defined as progression during or within 3 months of cessation.
. Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 4 weeks or 5 half-lives (whichever is shorter) prior to first study treatment.
. Current central nervous system, meningeal involvement or spinal cord compression by lymphoma. Previous involvement is permitted if there is currently no active CNS disease.
. Patients with active, known or suspected autoimmune disease. Patients with well controlled type I diabetes mellitus, coeliac disease, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, vitiligo or psoriasis not requiring systemic treatment, or other conditions not expected to recur in the absence of an external trigger are permitted to enrol.