Efficacy and Safety of Glofitamab Combined With GemOxin the Treatment of Refractory Diffuse Large B-Cell Lymphoma

March 14, 2026 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Efficacy and Safety of Glofitamab Combined With GemOx (Gemcitabine and Oxaliplatin) in the Treatment of Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Study

In patients with relapsed or refractory diffuse DLBCL who have not achieved complete remission in the mid-term, the treatment with Glofit+GemOx regimen is used.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Efficacy and Safety of Glofitamab Combined with GemOx (Gemcitabine and Oxaliplatin) in the Treatment of Refractory Diffuse Large B-Cell Lymphoma.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, beijing,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years;
  • DLBCL confirmed by pathological diagnosis according to the WHO 2016 classification;
  • PET-positive (Deauville score 4-5) according to Lugano response criteria after 3 cycles of first-line treatment;
  • No history or evidence of central nervous system involvement;
  • Adverse reactions from prior treatments have recovered to grade 1 or below (excluding clinically insignificant reactions such as hair loss);
  • ECOG performance status score ≤ 2;
  • Adequate bone marrow, kidney, liver, respiratory, and cardiac function: absolute neutrophil count ≥ 1000/μL; platelet count ≥ 75,000/μL; absolute lymphocyte count ≥ 100/μL; creatinine clearance ≥ 60 mL/min; ALT and AST ≤ 2.5 times the upper limit of normal; total bilirubin ≤ 1.5 mg/dL (except for Gilbert's syndrome); cardiac echocardiography showing ejection fraction ≥ 50% with no pericardial effusion (small or physiological effusions excluded); no clinically significant serosal effusions; baseline oxygen saturation > 92%;
  • The subject is able to understand the study protocol, is willing to participate in this study, and provides written informed consent.

Exclusion Criteria:

  • History of malignant tumors, excluding non-melanoma skin cancers or carcinoma in situ (cervix, bladder, breast), unless the disease has been in remission for at least 3 years;
  • Uncontrolled fungal, bacterial, viral, or other infections requiring intravenous anti-infective therapy;
  • Human immunodeficiency virus (HIV) infection, or acute/chronic active hepatitis B or C infection;
  • Malignant cells detectable in cerebrospinal fluid or active CNS lymphoma;
  • History of myocardial infarction, coronary artery bypass graft, or stent implantation within 12 months prior to enrollment;
  • History of deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment;
  • Female patients who are pregnant or breastfeeding, as determined by the investigator;
  • Inability of the subject to complete the study protocol or visits;
  • Presence of uncontrollable infection;
  • Currently participating in interventional study treatment, or having received other investigational drugs within 4 weeks prior to first dose (previous treatment with cetuximab, oxaliplatin, and gemcitabine is included);
  • Any other condition that the investigator deems the patient unsuitable for this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Refractory diffuse large B-cell lymphoma
1）. Age ≥18 years; 2）. DLBCL confirmed by WHO 2016 pathological classification; 3）. After 3 cycles of first-line treatment, PET-positive according to Lugano response criteria (Deauville score 4-5); 4）. No history or evidence of central nervous system involvement;
Drug: Glofitamab
On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.
Other Names:
  • Glofit
Drug: Gemcitabin
On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.
Other Names:
  • Gem
Drug: Oxaliplatin
On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.
Other Names:
  • Ox
Drug: Obinutuzumab
On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.
Other Names:
  • G

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate
Time Frame: From enrollment to the end of treatment at 8 weeks
Refers to the proportion of patients whose all detectable target lesions (such as tumor lesions or affected tissues) have completely disappeared after treatment with Glofitamab combined with GemOx, and this state lasts for at least 4 weeks. This condition needs to be confirmed through imaging examinations (such as CT, MRI, or PET-CT) and assessed comprehensively in combination with ctDNA.
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: From enrollment to the end of treatment at 8 weeks
The overall response rate (ORR) was defined as the cumulative proportion of patients attaining either a complete response (CR) or partial response (PR) .
From enrollment to the end of treatment at 8 weeks
OS
Time Frame: From enrollment to the end of treatment at 8 weeks
OS was measured from Golfitamab combined with GemOx initiation to death or last follow-up
From enrollment to the end of treatment at 8 weeks
PFS
Time Frame: From enrollment to the end of treatment at 8 weeks
PFS defined as the time from Glofitamab combined with GemOx initiation to first documented disease progression, relapse after Glofitamab combined with GemOx, death from any cause, or last follow-up.
From enrollment to the end of treatment at 8 weeks
DoR
Time Frame: From enrollment to the end of treatment at 8 weeks
It refers to the period of time from when a patient first achieves disease remission (such as tumor shrinkage reaching a certain percentage or significant improvement in symptoms) after receiving treatment, until the disease progresses again, relapses, or related adverse events (such as death) occur.
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Study Chair: Cao Xinxin, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 2, 2028

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 14, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 14, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCH0050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Clinical Trials on Glofitamab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe