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

ConditionDiffuse Large B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-A1912 Injection

    Drug

    SHR-A1912 injection.

  • Rituximab Injection

    Drug

    Rituximab injection.

  • Gemcitabine Hydrochloride for Injection

    Drug

    Gemcitabine hydrochloride for injection.

  • Oxaliplatin Injection

    Drug

    Oxaliplatin injection.

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: SHR-A1912 combined with Rituximab + Gemcitabine + OxaliplatinExperimental treatment 4 interventions
Group B: Rituximab + Gemcitabine + OxaliplatinActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Complete response rate (CRR)

Time frame
Up to 1 years following the first dose of the last enrolled patient.
2

Overall survival (OS)

Time frame
Up to 5 years following the first dose of the last enrolled patient.

Secondary outcomes

1

Adverse events (AEs)

Time frame
Up to 5 years following the first dose of the last enrolled patient.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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