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A prospective, single-center, single-arm clinical study evaluating the efficacy and safety of Glofitamab in combination with Gemox regimen in patients with diffuse large B-cell lymphoma who did not respond to the first-line therapy in interim evaluation

A prospective, single-center, single-arm clinical study evaluating the efficacy and safety of Glofitamab in combination with Gemox regimen in patients with diffuse large B-cell lymphoma who did not respond to the first-line therapy in interim evaluation

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086734
Enrollment
Unknown
Registered
2024-07-09
Start date
2024-07-15
Completion date
Unknown
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diffuse large B-cell lymphoma

Interventions

study group:Glofitamab plus Gemox

Sponsors

The first affiliated hospital Zhejiang University school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) According to the fifth edition of WHO Classification of lymphohematopoietic tumors, the patient was pathologically diagnosed as diffuse large B-cell lymphoma; 2) Age 18-65; 3) ECOG score: 0-2 4) After 2-4 courses of first-line anti-DLBCL regimen, PET-CT was evaluated as PD and SD; 5) PET-CT or CT/MRI shows at least one two-dimensional measurable lesion (maximum diameter > 1.5cm) 6) women of childbearing age must be confirmed by pregnancy test not pregnant, and are willing to take effective contraceptive measures during the test period and =12 months after the last dose; Pregnant and lactating women cannot participate; All male subjects used contraception during the study period and =3 months after the last dose; 7) Can provide informed consent, can understand and comply with the study requirements.

Exclusion criteria

Exclusion criteria: 1) Severe mental illness 2) HIV infection 3) previous regimen contain Glofitamab or Gemox

Design outcomes

Primary

MeasureTime frame
complete remission rate;

Secondary

MeasureTime frame
overall respond rate;Progression-free survival;overall survival;safety;

Countries

China

Contacts

Public ContactHongyan Tong

The first affiliated hospital Zhejiang University school of medicine

tonghongyan@zju.edu.cn+86 571 8723 5560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026