Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 18 to 70

Combining orelabrutinib with R-CHOP for treating newly diagnosed double expression DLBCL

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

Run by Shandong Cancer Hospital and Institute · NCT05933967 · Data updated 2026-11-12

This study is testing if adding orelabrutinib to the standard R-CHOP treatment can help people newly diagnosed with a specific aggressive type of lymphoma feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment31 (estimated)
SponsorShandong Cancer Hospital and Institute
Academic / other
Drugs / interventionsorelabrutinib
Locations2 sites (Nanchang, Jiangxi and 1 other locations)
StatusRecruiting
StartedJune 1, 2023
Main results expectedDecember 30, 2024
Study endsDecember 30, 2026
Registry record updatedAugust 15, 2023
Trial IDNCT05933967 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-70 with newly diagnosed double expression DLBCL and an ECOG performance status of 0-2.

Probably not a fit

Patients with systemic lymphoma involving the CNS or uncontrolled infections, cardiovascular diseases, or those preparing for transplantation may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, single-arm phase II study aims to evaluate the safety and efficacy of orelabrutinib in combination with the R-CHOP regimen for treatment-naïve patients diagnosed with double expression diffuse large B-cell lymphoma (DLBCL). Patients will receive 6 to 8 cycles of treatment, with each cycle lasting 21 days. The primary objective is to assess the complete response rate at the end of the induction therapy. This study seeks to provide a new treatment option for patients with this aggressive form of lymphoma.

Why it matters

Potential benefit: If successful, this treatment could improve response rates and outcomes for patients with double expression DLBCL.

How similar studies have gone: While this approach is novel in the context of double expression DLBCL, similar combinations have shown promise in other lymphoma studies.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • The First Ailliated Hospital of Nanchang University
    Nanchang, Jiangxi, China
    Recruiting
  • Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
    Jinan, Shandong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.