NCT05933967 A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
| NCT ID | NCT05933967 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shandong Cancer Hospital and Institute |
| Condition | The First Affiliated Hospital of Nanchang University |
| Study Type | INTERVENTIONAL |
| Enrollment | 31 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 31 participants in total. It began in 2023-06-01 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
zengjun Li
STUDY CHAIR
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT05933967 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying The First Affiliated Hospital of Nanchang University. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05933967 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05933967 currently recruiting?
Yes, NCT05933967 is actively recruiting participants. Contact the research team at zengjunli@163.com for enrollment information.
Where is the NCT05933967 trial being conducted?
This trial is being conducted at Nanchang, China, Jinan, China.
Who is sponsoring the NCT05933967 clinical trial?
NCT05933967 is sponsored by Shandong Cancer Hospital and Institute. The principal investigator is zengjun Li at Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences. The trial plans to enroll 31 participants.