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Recruiting NCT05933967

A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma

Phase II Interventional The First Affiliated Hospital of Nanchang University

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Orelabrutinib+R-CHOP.
Who it may be relevant to
Registry conditions: The First Affiliated Hospital of Nanchang University. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase II, Prospective ,Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma

Overview

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL.

Detailed description

The patients will be treated with 6/8 cycles of orelabrutinib plus R-CHOP regimen（21 days per cycle). The primary objective was the complete response rate (CRR) at end of induction therapy

Interventions

  • Drug Orelabrutinib+R-CHOP
    Orelabrutinib 150mg qd PO. Rituximab 375 mg/m2 IV on Day 0 of each 21-day cycle. The CHOP include cyclophosphamide, doxorubicin/Epirubicin/liposomal doxorubicin, vincristine/Vindesine, and prednison.

Primary outcome measures

  • complete response rate [Time frame: up to 24 weeks]
Secondary outcome measures (4)
  • ORR [Time frame: up to 24 weeks]
  • 2 years progression-free survival [Time frame: From date of receiving the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]]
  • 2 years overall survival [Time frame: From date of receiving the first dose until the date of death from any cause,assessed up to 2 years]
  • The occurrence of adverse events and serious adverse events [Time frame: up to 30 months]

Eligibility criteria

Inclusion criteria

  • Newly diagnosed Double Expression Diffuse Large B-cell Lymphoma
  • Age 18-70 years
  • ECOG performance status 0-2
  • Ann Arbor stage II-IV
  • 8.Subjects who in line with the testing standard of the clinical trial laboratory
  • Life expectancy ≥ 3months

Exclusion criteria

  • • systemic lymphoma involved CNS.
  • Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases.
  • uncontrolled infections (including HBV, HCV, HIV/AIDS)
  • Subjects who prepared for transplantation
  • Pregnancy or active lactation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • The First Ailliated Hospital of Nanchang University — Nanchang
  • Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Aca — Jinan

Identifiers

NCT: NCT05933967 · SDCHI-NHL-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗