Relapsed /Refractory DLBCLPhase 2Radio-GLONCT07634289
Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse Large B Cell Lymphoma
A Phase 2 study testing Glofitamab, Radiotherapy and Obinutuzumab in people with Relapsed /Refractory DLBCL, run by Olivia Newton-John Cancer Research Institute at 5 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed /Refractory DLBCL
- What is being tested?
- Glofitamab, Radiotherapy and Obinutuzumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesAustralia
- Study dates
- Dec 2026to Dec 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Adequate bone marrow function including:
- Haemoglobin >8.0 g/dL
- White cell count (WCC) ≥2000/μL
- Neutrophils >1.0 x 109/L
- Platelets >75 x 109/L at the time of study entry, unless attributed to lymphoma. Red cell transfusion is permitted.
- 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).
- Adequate hepatic function with AST/ALT ≤3x ULN and total bilirubin ≤1.5 x ULN (except subjects with Gilbert syndrome, who can have a total bilirubin ≤3 mg/dL or ≤51.3 μmol/L) unless attributed to lymphoma (e.g. liver infiltration or biliary obstruction).
- Adequate left ventricular ejection fraction of >40% as demonstrated on a Gated Cardiac Blood Pool Scan or echocardiogram.
- Life expectancy > 3 months.
- Patients of childbearing potential willing to adhere to the following contraceptive precautions:
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as defined below:
- Women must remain abstinent or use contraceptive methods with a failure rate of <1% per year during the treatment period and for at least 6 months after the final dose of obinutuzumab and 2 months after the final dose of glofitamab. Women must refrain from donating eggs during this same period.
- A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.
- Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. If required per local guidelines or regulations, locally recognized acceptable methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
- With a female partner of childbearing potential or pregnant female partners, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 6 months after obinutuzumab, and 2 months after the final dose of glofitamab or tocilizumab to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- Written, informed consent.
Who cannot join
- 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.
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- 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.
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration without prior discussion with the medical monitor. Inhaled or topical steroids, and adrenal replacement therapy are permitted in the absence of active autoimmune disease.
- Prior solid organ transplantation or allogeneic bone marrow transplantation within 6 months.
- Prior malignancy active within the previous 2 years except for those treated with curative intent and with a <20% chance of relapse. Low-grade prostate cancer under observation or well controlled on hormone therapy is permitted. Resected or locally treated non-melanoma skin cancer is permitted.
- Uncontrolled or severe cardiovascular disease (NYHA class III or IV heart failure; myocardial infarction within the last 6 months of study entry); unstable angina; unstable cardiac arrhythmias; clinically significant pericardial disease.
- Any other serious active disease or infection that in the opinion of the investigator takes precedence over the DLBCL, or will impact on the ability to deliver study treatment.
- Any positive test result for hepatitis B or hepatitis C virus during screening indicating acute or chronic infection. Latent hepatitis B with undetectable viral load by PCR is allowable provided appropriate anti-viral prophylaxis is given as per institutional guidelines.
- Any positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) unless the viral load is fully suppressed for >2 years with a CD4 count of >350x106/L and compliant with antiretroviral therapy.
- Any history of severe hypersensitivity reactions to other monoclonal antibodies.
- A history of allergy or intolerance (unacceptable AEs) to study drug components.
- Patients incarcerated or without Medicare
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Australia5 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Dr. Kate Manos, Kate.Manos@sa.gov.au
Townsville University Hospital
Douglas, Queensland
Dr. Joel Wight, Joel.Wight@health.qld.gov.au
Austin Hospital
Heidelberg, Victoria, 3084
Prof. Eliza Hawkes, eliza.hawkes@onjcri.org.au
Fiona Stanley Hospital
Murdoch, Western Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
A/Prof. Colm Keane, colm.keane@health.qld.gov.au
About this study
Official title: Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse Large B Cell Lymphoma: The Phase II Radio-GLO Study
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.
Read more
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.
Read the 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.
- Conditions
- Relapsed /Refractory DLBCL
- Being tested
- Glofitamab, Radiotherapy, Obinutuzumab, 89Zr-Df-crefmirlimab, 18F-granzyme B
- Keywords
- relapsed/refractory Diffuse Large B Cell lymphoma, Raditherapy, glofitamab, Radio-GLO, DLBCL, Obinutuzumab - Gazyva, Gazyvaro, Columvi
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlofitamabDrug
Also called Columvi
Glofitamab is the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more prior systemic therapies.
RadiotherapyRadiation
25 Gy in 5 fractions.
ObinutuzumabDrug
Also called Gazyva
Obinutuzumab as a pre-treatment to reduce the risk of CRS induced by glofitamab is approved in Australia.
89Zr-Df-crefmirlimabOther
Also called 89Zr-DF-IAB22M2C
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)
18F-granzyme BOther
Also called [AI18F]-NODA-CSB-321, CSB-321
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Drug: Glofitamab; Radiation: Radiotherapy; Drug: Obinutuzumab; Other: 89Zr-Df-crefmirlimab; Other: 18F-granzyme B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 37 weeks
Secondary outcomes (9)
Safety assessment through adverse events
The study will assess the safety and effectiveness of treatment, including side effects such as cytokine release syndrome (CRS) and infections. All adverse events will be graded according to CTCAE v 5.0.
Measured: 5 years total
Assessment of impact of side effects on patient's quality of life - EORTC-QLQ-C30
The EORTC QLQ-C30 is a patient-reported outcome measure that evaluates health-related quality of life across multiple domains. It includes five functional domains, physical, role, cognitive, emotional, and social functioning. As well as nine symptom domains covering fatigue, pain, nausea and vomiting, dyspnoea, appetite loss, insomnia, constipation, diarrhoea, and financial impact. In addition, it contains a global health status/quality-of-life scale. Responses are recorded using both 4-point and 7-point rating scales. Changes in global health status from baseline will be analysed. For the functional domains, higher scores indicate better levels of functioning, while higher scores on symptom domains represent greater symptom severity or burden.
Measured: 5 years
Overall Toxicity (all grades)
Overall Toxicity (all grades) and adverse events of special interest of treatment will be collected and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Measured: 5 years
Overall Response Rate to study treatment
Overall Response Rate as defined by the number of subjects with a best overall response of complete remission (CR), partial remission (PR) as assessed by CT plus PET, defined by the Lugano Response assessment for Non Hodgkin Lymphoma, at the completion of treatment or during the study.
Measured: 5 years
Time to Treatment failure
Time to Treatment failure will be calculated from the date of study enrolment until a progression event occurs. Progression events are defined as clinical or radiological documented disease progression.
Measured: 5 years
Progression-free Survival
Progression-free Survival will be calculated from the date of study enrolment until a progression event occurs, or death from any cause. Patients alive without progression will be censored at date last known to be alive.
Measured: 5 years
Overall survival
Overall survival will be measured from study entry to date of death from any cause; surviving patients will be censored at date last known to be alive.
Measured: 5 years
Assessment of impact of side effects on patient's quality of life - PRO-CTCAE
PRO-CTCAE assessments will be analysed to evaluate data integrity, describe baseline symptom burden, monitor symptom trajectories over time, assess the emergence and evolution of patient-reported adverse events, and explore concordance between patient-reported outcomes and investigator-rated adverse events. Results will be summarized descriptively by reporting the frequency and percentage of participants selecting each response level for each PRO-CTCAE item. Comparisons between treatment arms will be undertaken at the individual question level.
Measured: 5 years
Assessment of impact of side effects on patient's quality of life - EORTC-IL4
The EORTC-IL4 is a disease-specific quality-of-life instrument developed to supplement the EORTC QLQ-C30 by capturing additional symptoms and concerns relevant to the study population. Questionnaire responses will be summarised descriptively at each assessment time point. Scores will be calculated and transformed according to EORTC scoring guidelines, where applicable. Changes from baseline will be evaluated over time to assess the impact of treatment on patient-reported symptoms and health-related quality of life. Higher scores on symptom-related items indicate a greater symptom burden or level of concern, whereas higher scores on functioning-related items indicate better functioning and quality of life.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed /Refractory DLBCLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olivia Newton-John Cancer Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Fiona Stanley Hospital, Princess Alexandra Hospital, Brisbane, Australia, Austin Health, Townsville Hospital, Hoffmann-La Roche, Flinders Medical Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634289
- Sponsor's protocol ID
- ONJ2026-003
- Acronym
- Radio-GLO
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing to occur at publication.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse Large B Cell Lymphoma: The Phase II Radio-GLO Study
- ClinicalTrials.gov ID
- NCT07634289
- Acronym / sponsor ID
- Radio-GLO / ONJ2026-003
- Conditions
- Relapsed /Refractory DLBCL
- Keywords
- relapsed/refractory Diffuse Large B Cell lymphoma, Raditherapy, glofitamab, Radio-GLO, DLBCL, Obinutuzumab - Gazyva, Gazyvaro, Columvi
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Olivia Newton-John Cancer Research InstituteUniversity, hospital or other
- Collaborators
- Fiona Stanley Hospital, Princess Alexandra Hospital, Brisbane, Australia, Austin Health, Townsville Hospital, Hoffmann-La Roche, Flinders Medical Centre
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Glofitamab, Radiation: Radiotherapy, Drug: Obinutuzumab, Other: 89Zr-Df-crefmirlimab, Other: 18F-granzyme BRadiotherapy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlofitamabAlso: ColumviGlofitamab is the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more prior systemic therapies. | Drug | Intervention |
| Radiotherapy25 Gy in 5 fractions. | Radiation | Intervention |
| ObinutuzumabAlso: GazyvaObinutuzumab as a pre-treatment to reduce the risk of CRS induced by glofitamab is approved in Australia. | Drug | Intervention |
| 89Zr-Df-crefmirlimabAlso: 89Zr-DF-IAB22M2C89Zr-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) | Other | Intervention |
| 18F-granzyme BAlso: [AI18F]-NODA-CSB-321, CSB-321Eligible 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. | Other | Intervention |
Primary outcome
Complete Response Rate After Radiotherapy and Glofitamab Treatment
Time frame: 37 weeks
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
9 secondary outcomes
Safety assessment through adverse events
Time frame: 5 years total
Assessment of impact of side effects on patient's quality of life - EORTC-QLQ-C30
Time frame: 5 years
Overall Toxicity (all grades)
Time frame: 5 years
Overall Response Rate to study treatment
Time frame: 5 years
Time to Treatment failure
Time frame: 5 years
Progression-free Survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Assessment of impact of side effects on patient's quality of life - PRO-CTCAE
Time frame: 5 years
Assessment of impact of side effects on patient's quality of life - EORTC-IL4
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided. Data sharing to occur at publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glofitamab, Radiotherapy and Obinutuzumab in people with Relapsed /Refractory DLBCL, run by Olivia Newton-John Cancer Research Institute at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate After Radiotherapy and Glofitamab Treatment (time frame: 37 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.