Diffuse Large B Cell Lymphoma (DLBCL)Phase 2NCT07599423
A Study of Glofitamab Plus GemOx Compared With Standard of Care in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
A Phase 2 study testing Obinutuzumab, Glofitamab and Gemcitabine in people with Diffuse Large B Cell Lymphoma (DLBCL), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (GemOx) versus standard of care (SOC) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) who have relapsed early (within 1 year) or are primary refractory to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma (DLBCL)
- What is being tested?
- Obinutuzumab, Glofitamab and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2026to 31 Dec 2030
- 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
- Signed Informed Consent Form.
- Age 18 years or older at the time of signing the Informed Consent Form.
- Histologically proven diffuse large B-cell lymphoma (DLBCL), including transformation from follicular lymphoma.
- Relapsed or refractory disease after first-line chemoimmunotherapy, defined as refractory disease (no complete remission to first-line therapy, progressive disease as best response, stable disease after 3-4 cycles, or partial response after 6-8 cycles/progression within 12 months of first-line therapy) or relapsed disease (complete remission followed by biopsy-proven relapse within 12 months of first-line therapy).
- No known history or suspicion of central nervous system (CNS) involvement by lymphoma.
- Life expectancy of at least 12 weeks.
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- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- At least one bi-dimensionally measurable nodal lesion (1.5 cm or larger) or extranodal lesion (1 cm or larger) as measured on a CT scan.
- Negative HIV test at screening.
- Adequate hematologic function defined as hemoglobin 9.0 g/dL or higher without transfusion in the past 7 days, absolute neutrophil count 1.0 x 10^9/L or higher, and platelet count 75 x 10^9/L or higher.
- Adequate organ function defined as estimated creatinine clearance 60 mL/min or higher, ALT/AST 2.5 times the upper limit of normal (ULN) or lower, and total bilirubin 1.5 mg/dL or lower (or 3 x ULN or lower in subjects with Gilbert's syndrome).
- Cardiac ejection fraction greater than 50%, no evidence of pericardial effusion, and no clinically significant electrocardiogram findings.
- No clinically significant pleural effusion.
- Baseline oxygen saturation greater than 92% on room air.
- Able to understand and complete study-related questionnaires.
- Agreement to remain abstinent or use adequate contraceptive methods for both female and male participants during the treatment period and for the protocol-specified duration after the final dose.
Who cannot join
- Contraindication to glofitamab components or a history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
- Not eligible for autologous stem cell transplantation (ASCT).
- Prior solid organ transplantation.
- History of Richter's transformation or of indolent disease to diffuse large B-cell lymphoma (DLBCL) or primary mediastinal B-cell lymphoma (PMBCL).
- Peripheral neuropathy assessed to be greater than Grade 1 at enrollment.
- Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3.
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- Use of any investigational therapy for treating cancer within 28 days prior to Cycle 1, any monoclonal antibody within 3 months, or systemic immunotherapeutic agents within 4 weeks or five half-lives (whichever is shorter).
- Prior radiotherapy to the mediastinal or pericardial region.
- History of autologous or allogeneic stem cell transplant.
- Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better, except for alopecia and anorexia.
- Administration of a live, attenuated vaccine within 4 weeks before the first study treatment administration.
- Received more than one line of therapy for DLBCL.
- Corticosteroid use greater than 50 mg/day of prednisone or equivalent for purposes other than lymphoma symptom control.
- Recent major surgery within 4 weeks before the first study treatment.
- History of other malignancy that could affect compliance or interpretation of results, with exceptions for adequately treated low-grade or in situ carcinomas and malignancies in remission for at least 2 years.
- Significant cardiovascular disease, such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 3 months, unstable arrhythmias, or unstable angina.
- Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS lymphoma.
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
- Current or past history of Waldenstrom macroglobulinemia.
- History or presence of a clinically significant abnormal ECG.
- Known or suspected active infection, reactivation of a latent infection, or any major episode of infection requiring hospitalization or IV antibiotics within 4 weeks of dosing.
- History of severe treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents.
- History of autoimmune disease, with specific protocol-defined exceptions for well-controlled conditions.
- Clinically significant liver disease, including active viral/other hepatitis or cirrhosis.
- Abnormal coagulation laboratory values defined as INR or PT greater than 1.5 x ULN, or PTT/aPTT greater than 1.5 x ULN.
- Suspected active or latent tuberculosis.
- Positive test results for chronic hepatitis B infection (HBsAg positive) or positive test results for hepatitis C with positive HCV RNA.
- Diagnosis with SARS-CoV-2 infection within 30 days prior to first study treatment, or documented infection within 6 months with persistent respiratory symptoms.
- History of progressive multifocal leukoencephalopathy (PML).
- Pregnancy, breastfeeding, or intention of becoming pregnant during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Changju Qu, +86-512-67975805, qcj310@163.com
About this study
Official title: An Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Standard of Care in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
The purpose of this study is to evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (GemOx) versus standard of care (SOC) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) who have relapsed early (within 1 year) or are primary refractory to first-line therapy. Participants will be randomly assigned in a 1:1 ratio to receive either the Glofitamab-GemOx combination regimen or SOC. The SOC arm consists of investigator's choice of salvage chemoimmunotherapy followed by autologous stem cell transplantation (ASCT) for eligible patients. The primary endpoint of the study is event-free survival (EFS).
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Being tested
- Obinutuzumab, Glofitamab, Gemcitabine, Oxaliplatin, Salvage Chemotherapy (Investigator's Choice)
- 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.
ObinutuzumabDrug
A single 1000 mg dose is administered intravenously as pretreatment on Day 1 of Cycle 1 (7 days prior to the first glofitamab dose) to deplete peripheral B-cells and mitigate the risk of cytokine release syndrome (CRS).
GlofitamabDrug
Glofitamab is administered intravenously using a step-up dosing schedule to mitigate CRS:
Cycle 1 Day 8: 2.5 mg. Cycle 1 Day 15: 10 mg. Cycle 2-12 Day 1: 30 mg (target dose). Treatment continues for a maximum of 12 cycles (21-day cycles) or until disease progression/unacceptable toxicity.
GemcitabineDrug
Administered intravenously at 1000 mg/m² on Day 2 of Cycle 1, and then on Day 1 or 2 of subsequent cycles (Cycles 2-8).
OxaliplatinDrug
Administered intravenously at 100 mg/m² on Day 2 of Cycle 1, and then on Day 1 or 2 of subsequent cycles (Cycles 2-8).
Salvage Chemotherapy (Investigator's Choice)Drug
Participants in the SOC arm will receive up to 2 cycles of investigator's choice salvage therapy among the following regimens: ICE ± R, DHAP ± R, GDP ± R, ESHAP ± R, GemOx ± R, or MINE ± R .
Autologous Stem Cell Transplantation (ASCT)Drug
Participants in the SOC arm who achieve a CR or PR after salvage therapy will proceed to ASCT. This includes a conditioning regimen (e.g., BEAM) followed by autologous stem cell rescue and a recovery period.
| Study group | Role | What they receive |
|---|---|---|
| Glofit-GemOx | Experimental | Not described Receives: Drug: Obinutuzumab; Drug: Glofitamab; Drug: Gemcitabine; Drug: Oxaliplatin |
| SoC | Active comparator | Not described Receives: Drug: Salvage Chemotherapy (Investigator's Choice); Drug: Autologous Stem Cell Transplantation (ASCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival (EFS)
EFS is defined as the time from randomization to the earliest date of disease progression according to the Lugano Classification (2014), commencement of new anti-lymphoma therapy, or death from any cause, as determined by the investigator.
Measured: From randomization until the first occurrence of an EFS event (disease progression, new therapy, or death), assessed up to approximately 48 months.
Secondary outcomes (10)
Complete Response (CR) Rate
The proportion of participants whose best overall response is a CR on PET/CT or diagnostic CT during the study, as determined by the investigator according to the 2014 Lugano Response Criteria.
Measured: From randomization to the end of study, up to approximately 48 months.
Objective Response Rate (ORR)
The proportion of participants whose best overall response is a Partial Response (PR) or a Complete Response (CR) during the study, as determined by the investigator according to the 2014 Lugano Response Criteria.
Measured: From randomization to the end of study, up to approximately 48 months.
Progression-Free Survival (PFS)
The time from randomization to the first occurrence of disease progression according to the 2014 Lugano Response Criteria or death from any cause, whichever occurs first, as determined by the investigator.
Measured: From randomization until disease progression or death, assessed up to approximately 48 months.
Duration of Response (DOR)
The time from the first occurrence of a documented objective response (CR or PR) to disease progression or death from any cause, whichever occurs first.
Measured: From the date of first documented objective response until disease progression or death, assessed up to approximately 48 months.
Duration of Complete Response (DOCR)
The time from the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first.
Measured: From the date of first documented CR until disease progression or death, assessed up to approximately 48 months.
Overall Survival (OS)
The time from randomization to the date of death from any cause.
Measured: From randomization until death, assessed up to approximately 48 months.
Incidence and Severity of Adverse Events (AEs)
Safety and tolerability evaluated by the incidence and severity of AEs. Severity is determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0). Specific events such as CRS, Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and Hemophagocytic Lymphohistiocytosis (HLH) will be graded according to ASTCT criteria.
Measured: From the initiation of study treatment up to 35 days after the final dose or initiation of new anti-lymphoma therapy, with long-term monitoring for specific AEs, assessed up to approximately 48 months.
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
The EORTC QLQ-C30 assesses 5 functional scales, 3 symptom scales, a global health/quality of life (QoL) scale, and 6 single items. The first 28 items are scored on a 4-point scale ranging from 1 ("not at all") to 4 ("very much"). The final 2 global health/QoL items are scored on a 7-point scale ranging from 1 ("very poor") to 7 ("excellent"). Higher scores on the global health/QoL and functional scales indicate a better level of functioning and better HRQoL (a better outcome). Conversely, higher scores on the symptom scales/items indicate higher symptom severity (a worse outcome).
Measured: Baseline up to approximately 48 months.
Change from Baseline in Functional Assessment of Cancer Therapy-Lymphoma Symptoms Subscale (FACT-Lym LymS) Score
The FACT-Lym LymS assesses health-related quality of life aspects relevant to lymphoma patients using a 15-item lymphoma-specific symptoms scale. Each item is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). Higher total scores are indicative of better health-related quality of life (a better outcome).
Measured: Baseline up to approximately 48 months.
Change from Baseline in EuroQoL-5 Dimension-5 Level (EQ-5D-5L) Score
The EQ-5D-5L is a health status questionnaire containing a five-item descriptive system (assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a Visual Analog Scale (VAS). The VAS measures the patient's self-rated health on a vertical scale ranging from 0 ("worst imaginable health state") to 100 ("best imaginable health state"). A published weighting system is used to create a single composite score of the patient's health status. Higher scores on the VAS and the composite utility score indicate a better health status (a better outcome).
Measured: Baseline up to approximately 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start22 Jul 2026 (estimated)
- Primary completion21 Jul 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell Lymphoma (DLBCL)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, QU CHANGJU, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599423
- Sponsor's protocol ID
- ML46548
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Standard of Care in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07599423
- Acronym / sponsor ID
- ML46548
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 22 Jul 2026 (estimated)
- Primary completion
- 21 Jul 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 May 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 purpose of this study is to evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (GemOx) versus standard of care (SOC) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) who have relapsed early (within 1 year) or are primary refractory to first-line therapy. Participants will be randomly assigned in a 1:1 ratio to receive either the Glofitamab-GemOx combination regimen or SOC. The SOC arm consists of investigator's choice of salvage chemoimmunotherapy followed by autologous stem cell transplantation (ASCT) for eligible patients. The primary endpoint of the study is event-free survival (EFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glofit-GemOx | Experimental | Drug: Obinutuzumab, Drug: Glofitamab, Drug: Gemcitabine, Drug: Oxaliplatin |
| SoC | Active comparator | Drug: Salvage Chemotherapy (Investigator's Choice), Drug: Autologous Stem Cell Transplantation (ASCT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed Informed Consent Form.
- Age 18 years or older at the time of signing the Informed Consent Form.
- Histologically proven diffuse large B-cell lymphoma (DLBCL), including transformation from follicular lymphoma.
- Relapsed or refractory disease after first-line chemoimmunotherapy, defined as refractory disease (no complete remission to first-line therapy, progressive disease as best response, stable disease after 3-4 cycles, or partial response after 6-8 cycles/progression within 12 months of first-line therapy) or relapsed disease (complete remission followed by biopsy-proven relapse within 12 months of first-line therapy).
- No known history or suspicion of central nervous system (CNS) involvement by lymphoma.
Key exclusion criteria (30 listed)
- Contraindication to glofitamab components or a history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
- Not eligible for autologous stem cell transplantation (ASCT).
- Prior solid organ transplantation.
- History of Richter's transformation or of indolent disease to diffuse large B-cell lymphoma (DLBCL) or primary mediastinal B-cell lymphoma (PMBCL).
- Peripheral neuropathy assessed to be greater than Grade 1 at enrollment.
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 |
|---|---|---|
| ObinutuzumabA single 1000 mg dose is administered intravenously as pretreatment on Day 1 of Cycle 1 (7 days prior to the first glofitamab dose) to deplete peripheral B-cells and mitigate the risk of cytokine release syndrome (CRS). | Drug | Glofit-GemOx |
| GlofitamabGlofitamab is administered intravenously using a step-up dosing schedule to mitigate CRS: Cycle 1 Day 8: 2.5 mg. Cycle 1 Day 15: 10 mg. Cycle 2-12 Day 1: 30 mg (target dose). Treatment continues for a maximum of 12 cycles (21-day cycles) or until disease progression/unacceptable toxicity. | Drug | Glofit-GemOx |
| GemcitabineAdministered intravenously at 1000 mg/m² on Day 2 of Cycle 1, and then on Day 1 or 2 of subsequent cycles (Cycles 2-8). | Drug | Glofit-GemOx |
| OxaliplatinAdministered intravenously at 100 mg/m² on Day 2 of Cycle 1, and then on Day 1 or 2 of subsequent cycles (Cycles 2-8). | Drug | Glofit-GemOx |
| Salvage Chemotherapy (Investigator's Choice)Participants in the SOC arm will receive up to 2 cycles of investigator's choice salvage therapy among the following regimens: ICE ± R, DHAP ± R, GDP ± R, ESHAP ± R, GemOx ± R, or MINE ± R . | Drug | SoC |
| Autologous Stem Cell Transplantation (ASCT)Participants in the SOC arm who achieve a CR or PR after salvage therapy will proceed to ASCT. This includes a conditioning regimen (e.g., BEAM) followed by autologous stem cell rescue and a recovery period. | Drug | SoC |
Primary outcome
Event-Free Survival (EFS)
Time frame: From randomization until the first occurrence of an EFS event (disease progression, new therapy, or death), assessed up to approximately 48 months.
EFS is defined as the time from randomization to the earliest date of disease progression according to the Lugano Classification (2014), commencement of new anti-lymphoma therapy, or death from any cause, as determined by the investigator.
10 secondary outcomes
Complete Response (CR) Rate
Time frame: From randomization to the end of study, up to approximately 48 months.
Objective Response Rate (ORR)
Time frame: From randomization to the end of study, up to approximately 48 months.
Progression-Free Survival (PFS)
Time frame: From randomization until disease progression or death, assessed up to approximately 48 months.
Duration of Response (DOR)
Time frame: From the date of first documented objective response until disease progression or death, assessed up to approximately 48 months.
Duration of Complete Response (DOCR)
Time frame: From the date of first documented CR until disease progression or death, assessed up to approximately 48 months.
Overall Survival (OS)
Time frame: From randomization until death, assessed up to approximately 48 months.
Incidence and Severity of Adverse Events (AEs)
Time frame: From the initiation of study treatment up to 35 days after the final dose or initiation of new anti-lymphoma therapy, with long-term monitoring for specific AEs, assessed up to approximately 48 months.
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Time frame: Baseline up to approximately 48 months.
Change from Baseline in Functional Assessment of Cancer Therapy-Lymphoma Symptoms Subscale (FACT-Lym LymS) Score
Time frame: Baseline up to approximately 48 months.
Change from Baseline in EuroQoL-5 Dimension-5 Level (EQ-5D-5L) Score
Time frame: Baseline up to approximately 48 months.
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 13 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obinutuzumab, Glofitamab and Gemcitabine in people with Diffuse Large B Cell Lymphoma (DLBCL), run by The First Affiliated Hospital of Soochow University at 1 site in China.
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 16 inclusion and 30 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Contact Changju Qu (+86-512-67975805, qcj310@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Free Survival (EFS) (time frame: From randomization until the first occurrence of an EFS event (disease progression, new therapy, or death), assessed up to approximately 48 months.). 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 13 Jul 2026.