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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 31 (estimated) |
| Sponsor | Shandong Cancer Hospital and Institute Academic / other |
| Drugs / interventions | orelabrutinib |
| Locations | 2 sites (Nanchang, Jiangxi and 1 other locations) |
| Status | Recruiting |
| Started | June 1, 2023 |
| Main results expected | December 30, 2024 |
| Study ends | December 30, 2026 |
| Registry record updated | August 15, 2023 |
| Trial ID | NCT05933967 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
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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
- Study coordinator: zengjun Li
- Email: zengjunli@163.com
- Phone: 13642138692
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL
This trial tests whether adding orelabrutinib to the Pola-R-CHP regimen can improve outcomes for adults with intermediate- to high-risk newly diagnosed DLBCL.
-
Orelabrutinib with Obinutuzumab and Short-Course Venetoclax in Treatment-Naïve Mantle Cell Lymphoma
This trial tests whether a combo of orelabrutinib, obinutuzumab, and a short course of venetoclax is safe and effective for adults with newly diagnosed mantle cell lymphoma.
-
Orelabrutinib plus standard immunochemotherapy with or without auto-HSCT for newly diagnosed DLBCL
This study tests whether adding orelabrutinib to standard chemotherapy, with or without autologous stem cell transplantation, helps newly diagnosed DLBCL patients.
-
High-dose dexamethasone plus orelabrutinib versus placebo for newly diagnosed adult ITP
This trial tests whether adding orelabrutinib to high-dose dexamethasone helps adults newly diagnosed with primary ITP raise and maintain their platelet counts compared with placebo.
-
Ultra-low-dose radiation followed by orelabrutinib for early-stage MALT lymphoma
This study will test whether a short course of very low-dose radiation followed by daily orelabrutinib helps adults with stage I–II MALT lymphoma keep their disease controlled with acceptable side effects.
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Orelabrutinib for relapsed or refractory AIHA
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.