A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Diffuse Large B-cell Lymphoma

Treatments: Drug: Oxaliplatin Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: SHR-A1912 Injection; Drug: Rituximab Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06929624

SHR-A1912-301

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin

Experimental group

Treatment:

Drug: Rituximab Injection

Drug: SHR-A1912 Injection

Drug: Gemcitabine Hydrochloride for Injection

Drug: Oxaliplatin Injection

Rituximab + Gemcitabine + Oxaliplatin

Active Comparator group

Treatment:

Drug: Rituximab Injection

Drug: Gemcitabine Hydrochloride for Injection

Drug: Oxaliplatin Injection