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Taking people in ChinaPhase 2

Tests orelabrutinib with R-CHOP in newly diagnosed double expression large B-cell lymphoma

Tests orelabrutinib plus R-CHOP chemotherapy in adults newly diagnosed with double expression lymphoma.

Plain-language title generated from the registry record
Registry title: A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma

Key facts

Where
Jinan and Nanchang, ChinaSee the 2 sites
Phase
Phase 2

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Source: NCT05933967, who can take part

Where in China

  • Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical SciencesJinan, ChinaTaking people
  • The First Ailliated Hospital of Nanchang UniversityNanchang, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Shandong Cancer Hospital and Institute
Trial code
NCT05933967
Record updated
15 August 2023
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: • 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.

ClinicalTrials.gov NCT05933967