NCT07480850

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
18mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Jan 2026Jan 2028

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2028

Last Updated

March 18, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

March 14, 2026

Last Update Submit

March 14, 2026

Conditions

Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Outcome Measures

Primary Outcomes (1)

  • Complete Response Rate

    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 Outcomes (4)

  • ORR

    From enrollment to the end of treatment at 8 weeks

  • OS

    From enrollment to the end of treatment at 8 weeks

  • PFS

    From enrollment to the end of treatment at 8 weeks

  • DoR

    From enrollment to the end of treatment at 8 weeks

Study Arms (1)

Refractory diffuse large B-cell lymphoma

EXPERIMENTAL

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: GlofitamabDrug: GemcitabinDrug: OxaliplatinDrug: Obinutuzumab

Interventions

GlofitamabDRUG

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.

Also known as: Glofit
Refractory diffuse large B-cell lymphoma
GemcitabinDRUG

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.

Also known as: Gem
Refractory diffuse large B-cell lymphoma
OxaliplatinDRUG

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.

Also known as: Ox
Refractory diffuse large B-cell lymphoma
ObinutuzumabDRUG

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.

Also known as: G
Refractory diffuse large B-cell lymphoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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,

Beijing, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

glofitamabGemcitabineOxaliplatinobinutuzumab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Study Officials

  • Cao Xinxin

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2026

First Posted

March 18, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 2, 2028

Last Updated

March 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)