A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A1912 Injection, Rituximab Injection, Gemcitabine Hydrochloride for Injection, Oxaliplatin Injection.
- Who it may be relevant to
- Registry conditions: Diffuse Large B-cell Lymphoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug SHR-A1912 Injection
SHR-A1912 injection. - Drug Rituximab Injection
Rituximab injection. - Drug Gemcitabine Hydrochloride for Injection
Gemcitabine hydrochloride for injection. - Drug Oxaliplatin Injection
Oxaliplatin injection.
Primary outcome measures
- Complete response rate (CRR) [Time frame: Up to 1 years following the first dose of the last enrolled patient.]
- Overall survival (OS) [Time frame: Up to 5 years following the first dose of the last enrolled patient.]
Secondary outcome measures (1)
- Adverse events (AEs) [Time frame: Up to 5 years following the first dose of the last enrolled patient.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Beijing Cancer Hospital — Beijing
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT06929624 · SHR-A1912-301