Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DLBCL - Diffuse Large B Cell Lymphoma | Interdigitating Dendritic Cell Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hi-miniCHOP +orelabrutinib | Drug | — | UNRESOLVED |
| HiMTO | Drug | — | UNRESOLVED |
| POLA-Hi-CHP+orelabrutinib | Drug | — | UNRESOLVED |
| Pola-Hi-miniCHP | Drug | — | UNRESOLVED |
| POLA-R-CHP+orelabrutinib | Drug | — | UNRESOLVED |
| Pola-R-miniCHP+O | Drug | — | UNRESOLVED |
| R-CHOP+Orelabrutinib | Drug | — | UNRESOLVED |
| R-miniCHOP +orelabrutinib | Drug | — | UNRESOLVED |
| RMTO | Drug | — |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCL
- description
- For MCD subtype DLBCL (including IP-LBCLs) that have undergone two cycles of induction therapy, combine orelabrutinib treatment starting from the third cycle. For patients with poor prognostic factors (meeting one of the following: Ann Arbor stage III/IV; IPI score 3-5; aaIPI score 2-3; high-intermediate or high-risk group per MSKCC and/or IELSG criteria), continue with two additional cycles of orelabrutinib-combined induction therapy, followed by orelabrutinib monotherapy maintenance for 2 years or until disease progression or intolerable toxicity. For patients without poor prognostic factors, administer orelabrutinib monotherapy maintenance for 1 year or until disease progression or intolerable toxicity.
- interventionNames
- Drug: R-CHOP+Orelabrutinib
- Drug: POLA-R-CHP+orelabrutinib
- Drug: R-miniCHOP +orelabrutinib
- Drug: Zuberitamab-CHOP+orelabrutinib
- Drug: POLA-Hi-CHP+orelabrutinib
- Drug: Hi-miniCHOP +orelabrutinib
- Drug: RMTO
- Drug: HiMTO
- Drug: Pola-R-miniCHP+O
- Drug: Pola-Hi-miniCHP
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available