Evaluating SHR-A1912 with R-GemOx for treating 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
This study is testing if a new treatment called SHR-A1912, when combined with R-GemOx, can help people with relapsed diffuse large B-cell lymphoma feel better and live longer compared to just R-GemOx alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06929624 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, open-label phase 3 clinical study aims to assess the efficacy of SHR-A1912 when combined with R-GemOx in patients with relapsed refractory diffuse large B-cell lymphoma (DLBCL). Participants will receive either the combination treatment or R-GemOx alone, and the study will measure outcomes related to tumor response and patient survival. The trial includes patients who have histologically confirmed DLBCL and have undergone at least one prior line of systemic therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with histologically confirmed DLBCL who have received at least one prior line of therapy.
Not a fit: Patients with central nervous system lymphoma involvement or those with a history of severe cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with relapsed DLBCL.
How similar studies have performed: Other studies have shown promise in using combination therapies for DLBCL, but the specific combination of SHR-A1912 with R-GemOx is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed diffuse large B-cell lymphoma (DLBCL). 2. Have received ≥1 line of systemic antitumor therapy. 3. At least one bi-dimensionally measurable lesion. 4. Expected survival of at least 3 months. 5. Age ≥18 years old and under 80 years old. 6. The patients voluntarily participated in the study, signed informed consent, had good compliance and were willing to cooperate with follow-up. Exclusion Criteria: 1. Central nervous system lymphoma involvement. 2. Primary mediastinal (thymus) large B-cell lymphoma. 3. Patients who have only one prior line therapy and are candidates for stem cell transplantation. 4. A history of immunodeficiency. 5. A history of severe cardiovascular disease. 6. A history of other malignancies within 5 years prior to administration of the first dose.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Mengbo Zhao
- Email: mengbo.zhao@hengrui.com
- Phone: +86-0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.