Orelabrutinib with chemotherapy for MCD subtype diffuse large B-cell lymphoma
Tests orelabrutinib plus chemotherapy, then maintenance, in adults with MCD subtype diffuse large B-cell lymphoma.
Plain-language title generated from the registry record
Registry title: Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma
Key facts
- Where
- Changchun, ChinaSee the site
- Phase
- Phase 2
Where in China
- The First Bethune Hospital of Jilin UniversityChangchun, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ou Bai, MD/PHD
- Trial code
- NCT07677813
- Record updated
- 1 July 2026
- Original description
This is a single-center, single-arm, prospective study aimed at evaluating the efficacy and safety of orelabrutinib combined with an induction regimen followed by monotherapy maintenance in patients with MCD subtype diffuse large B-cell lymphoma (DLBCL). The primary endpoint is the 2-year progression-free survival (PFS) rate; secondary endpoints include overall response rate (ORR), complete response rate (CRR), overall survival (OS), and treatment-related adverse events (TRAEs). The study plans to enroll 66 patients.Read full original descriptionShow less
Efficacy and Safety of Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma: a Single-center, Single-arm, Prospective Study
This is a single-center, single-arm, prospective study aimed at evaluating the efficacy and safety of orelabrutinib combined with an induction regimen followed by monotherapy maintenance in patients with MCD subtype diffuse large B-cell lymphoma (DLBCL). The primary endpoint is the 2-year progression-free survival (PFS) rate; secondary endpoints include overall response rate (ORR), complete response rate (CRR), overall survival (OS), and treatment-related adverse events (TRAEs). The study plans to enroll 66 patients.
Inclusion: Patients of any gender, aged ≥18 years; Pathologically, NGS, and imaging confirmed diagnosis of MCD subtype DLBCL (including IP-LBCLs); No prior treatment history; Serum creatinine ≤2 times the upper limit of normal or eGFR ≥40 ml/min; Bilirubin <1.5 times the upper limit of normal; Understand and voluntarily sign a written informed consent form.
Exclusion: Patients requiring treatment with strong CYP3A inhibitors; Patients with a history of or concurrent other malignant tumors; Patients with a history of stroke or bleeding within the past 6 months; Patients with comorbid autoimmune deficiency diseases or active hepatitis virus infection; Patients with a history of organ transplantation; Pregnant or lactating women and women of childbearing age who are unwilling to use contraception.