NCT07677813Not yet recruitingPhase 2
Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma
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
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 22 Jun 2026
- Start date
- 16 Jun 2026
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Ou Bai, MD/PHD
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT07677813
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 66
- From 16 Jun 2026 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients requiring treatment with strong CYP3A inhibitors;
- Patients with a history of or concurrent other malignant tumors.
Other illness
- 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;
Age
- Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Bethune Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.