A Phase 2 interventional study of Glofitamab and Radiotherapy in Relapsed /Refractory DLBCL, sponsored by Olivia Newton-John Cancer Research Institute. Not yet recruiting at 5 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Olivia Newton-John Cancer Research Institute · Phase 2, Interventional, and Treatment
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.
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.
1,868 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 355 are open to participants now.
This study's planned enrollment of 40 is below the median of 45 across 1,497 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Olivia Newton-John Cancer Research Institute is the lead sponsor of 14 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate bone marrow function including:
Patients of willing to adhere to the following 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 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 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Glofitamab · Radiation: Radiotherapy · Drug: Obinutuzumab · Other: 89Zr-Df-crefmirlimab · Other: 18F-granzyme B
Glofitamab is the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more prior systemic therapies.
Also known as: Columvi
25 Gy in 5 fractions.
Obinutuzumab as a pre-treatment to reduce the risk of CRS induced by glofitamab is approved in Australia.
Also known as: Gazyva
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)
Also known as: 89Zr-DF-IAB22M2C
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.
Also known as: [AI18F]-NODA-CSB-321, CSB-321
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
Time frame: 37 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 years
Blood markers linked to treatment response and side effects
Blood samples will be used for biomarker analysis, which will include but is not limited to: DNA (deoxyribonucleic acid) genotyping, RNA (ribonucleic acid) and/or miRNA (micro-RNA) expression, ctDNA analysis and soluble serum/plasma factors related to immune and tumour response in order to correlate potential biomarkers with treatment responses and toxicity.
Time frame: 5 years
Gut bacteria changes linked to treatment response and side effects
Studying whether changes in gut bacteria are associated with how patients respond to treatment and their risk of side effects.
Time frame: 5 years
Advanced PET scan measures
Change from baseline in PET radiomic features associated with intra-tumoral activated T-cell infiltration after cycle 2 of glofitamab. CT imaging in this instance will be used to 'locate' the tumor and will not be used for diagnostic purposes.
Time frame: 12 months
Tissue markers linked to treatment response and side effects
Tissue samples will be collected to evaluate the role of prognostic and predictive biomarkers. Tissue samples will be collected (core biopsies-minimum of 3, ideally 5-6 cores- or surgical biopsies as part of the standard study assessments and should be preserved as formalin-fixed paraffin-embedded (FFPE) specimens.
Time frame: 5 years
Plan to share: Undecided — Data sharing to occur at publication.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Glofitamab
Lymphoma, Large B-Cell, Diffuse →
Olivia Newton-John Cancer Research Institute