Health TrialsbyHealthPanel

Zanubrutinib Combined With R-CHOP in the Treatment of Newly Diagnosed DLBCL With p53 Protein Expression

ConditionDiffuse Large B Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuazhong University of Science and Technology

About this trial

This study aim to evaluate the efficacy and safety of zanubrutinib combined with R-CHOP in the treatment of DLBCL patients with p53 protein expression.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years, ≤ 75 years, both sexes;

Diff use large B-cell lymphoma diagnosed by histopathology without previous systemic DLBCL treatment;

ECOG score: 0-2;

Predicted survival ≥3 months;

Disqualifiers

Patients with definite lymphoma central nervous system (CNS) infiltration, including brain parenchyma, meningeal invasion, or spinal cord compression;

severe or uncontrolled infection;

with active autoimmune disease;

Other serious medical conditions, such as uncontrolled diabetes, gastric ulcers, other serious cardiopulmonary diseases, etc. (the decision was left to the investigator);

Trial design

Design model

Single group

Treatments tested in this trial

  • Zanubrutinib plus RCHOP

    Drug

    Rituximab 375mg/m2 D1; cyclophosphamide 750mg/m2 D2; adriamycin 50 mg/m2 D2 vincristine 1.4mg/m(Max 2mg) D2; prednisone 100mg/d D2-6; Zanubrutinib 160 mg, bid D1-21

Treatment groups

41 Participants
are divided into 1 treatment group
Group A: Z-RCHOPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete response rate (CRR)

To evaluate the efficacy of anti-lymphoma

Time frame
At the end of cycle 6 (each cycle is 21 days )

Secondary outcomes

1

Overall response rate (ORR)

To evaluate the efficacy of anti-lymphoma

Time frame
At the end of cycle 6 (each cycle is 21 days )
2

Progression-free survival (PFS)

To evaluate the efficacy of anti-lymphoma

Time frame
From date of initiation therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
3

Overall survival (OS)

To evaluate the efficacy of anti-lymphoma

Time frame
From date of initiation therapy until the date of death from any cause, assessed up to 60 months
4

Rate of AE and SAE

To identify the incidence of AE and SAE in clinical trial

Time frame
from the initiation of the first dose to 28 days after the last dose

Other outcomes

Sponsors and contacts

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

Huazhong University of Science and Technology

Lead sponsor

Source ClinicalTrials.gov
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