Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma
Starting soon · Phase 2
Conditions studied: DLBCL - Diffuse Large B Cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT07677813
- Run by
- Ou Bai, MD/PHD
- People needed
- 66
- Starts
- 2026-06-16
- Expected to finish
- 2031-12-31
- Last updated by the study team
- 2026-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;
- Patients with a history of stroke or bleeding within the past 6 months;
- Patients requiring treatment with strong CYP3A inhibitors;
- Patients with comorbid autoimmune deficiency diseases or active hepatitis virus infection;
- Patients with a history of organ transplantation;
- Patients with a history of or concurrent other malignant tumors.
Where it is running
- The First Bethune Hospital of Jilin University — Changchun, Jilin, China
Full record on ClinicalTrials.gov
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