Actively Recruiting
A Phase 3, Open-label, Randomized Study of SHR-A1912 Combined With Rituximab Gemcitabine Oxaliplatin Versus R-GemOx in Relapsed or Refractory Diffuse Large B-cell Lymphoma
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-11-18
280
Participants Needed
2
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, randomized, open-label phase 3 clinical trial to evaluate the effectiveness of SHR-A1912 combined with R-GemOx compared to R-GemOx alone in patients with relapsed or refractory diffuse large B-cell lymphoma. This study is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd and aims to assess treatment responses and survival in this patient population. Participants will receive either SHR-A1912 combined with Rituximab, Gemcitabine, and Oxaliplatin R-GemOx or R-GemOx alone. The study design includes random assignment to one of these two treatment groups. The treatments involve injections of SHR-A1912, Rituximab, Gemcitabine hydrochloride, and Oxaliplatin. The study will monitor patients over time to compare the outcomes between the combined therapy and standard R-GemOx. During the trial, researchers will assess the complete response rate up to one year after the first dose of the last enrolled patient and overall survival up to five years after that dose. They will also monitor adverse events over five years. Participants will undergo regular evaluations and follow-up visits to track treatment effects, safety, and survival outcomes throughout the study duration.
CONDITIONS
Brief Title
A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL)
- Have received at least 1 line of systemic antitumor therapy
- At least one bi-dimensionally measurable lesion
- Expected survival of at least 3 months
- Age 18 years or older and under 80 years old
- Voluntary participation with signed informed consent, good compliance, and willingness to cooperate with follow-up
You will not qualify if you...
- Central nervous system lymphoma involvement
- Primary mediastinal (thymus) large B-cell lymphoma
- Only one prior line therapy and candidate for stem cell transplantation
- History of immunodeficiency
- History of severe cardiovascular disease
- History of other malignancies within 5 years prior to first dose
Research Team
M
Mengbo Zhao
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