Diffuse Large B-cell Lymphoma
Conditions
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.
Interventions
DRUGSHR-A1912 Injection
SHR-A1912 injection.
Rituximab injection.
DRUGGemcitabine Hydrochloride for Injection
Gemcitabine hydrochloride for injection.
Oxaliplatin injection.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Adverse events (AEs) | Up to 5 years following the first dose of the last enrolled patient. |
Countries
China
Contacts
Primary ContactMengbo Zhao
Outcome results
None listed