A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma
A Phase 3, Open-label, Randomized Study of SHR-A1912 Combined With Rituximab + Gemcitabine + Oxaliplatin (R-GEMOX) Versus R-GEMOX in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
1 other identifier
interventional
280
1 country
2
Brief Summary
This is a multicenter, randomized, open-label, phase 3 clinical study to evaluate the efficacy of SHR-A1912 combined with R-GemOx in relapsed refractory diffuse large B-cell lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2025
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2025
CompletedFirst Posted
Study publicly available on registry
April 16, 2025
CompletedStudy Start
First participant enrolled
April 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
November 18, 2025
November 1, 2025
1.9 years
April 8, 2025
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Complete response rate (CRR)
Up to 1 years following the first dose of the last enrolled patient.
Overall survival (OS)
Up to 5 years following the first dose of the last enrolled patient.
Secondary Outcomes (1)
Adverse events (AEs)
Up to 5 years following the first dose of the last enrolled patient.
Study Arms (2)
SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin
EXPERIMENTALRituximab + Gemcitabine + Oxaliplatin
ACTIVE COMPARATORInterventions
SHR-A1912 injection.
Rituximab injection.
Gemcitabine hydrochloride for injection.
Oxaliplatin injection.
Eligibility Criteria
You may qualify if:
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL).
- Have received ≥1 line of systemic antitumor therapy.
- At least one bi-dimensionally measurable lesion.
- Expected survival of at least 3 months.
- Age ≥18 years old and under 80 years old.
- The patients voluntarily participated in the study, signed informed consent, had good compliance and were willing to cooperate with follow-up.
You may not qualify if:
- Central nervous system lymphoma involvement.
- Primary mediastinal (thymus) large B-cell lymphoma.
- Patients who have only one prior line therapy and are candidates for stem cell transplantation.
- A history of immunodeficiency.
- A history of severe cardiovascular disease.
- A history of other malignancies within 5 years prior to administration of the first dose.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2025
First Posted
April 16, 2025
Study Start
April 24, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
November 18, 2025
Record last verified: 2025-11