drugset
drugset / Trial / NCT07677813

Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma

NCT07677813 ↗

Phase 2 Not yet recruiting 66 enrolled Ou Bai, MD/PHD
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-06-16
Primary completion
2029-12-31
Completion
2031-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Orelabrutinib Small molecule 150 mg —
Background Cyclophosphamide Other / unclassified 1.8 mg/kg —
Background Cyclophosphamide Other / unclassified 400 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 25 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Background Methotrexate Small molecule 3.5 g —
Background Polatuzumab Vedotin Other / unclassified 1.8 mg/kg Intravenous
Background Prednisone Other / unclassified 40 mg/m2 Oral
Background Prednisone Other / unclassified 100 mg Oral
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Thiotepa Other / unclassified 30 mg/m2 —
Background Vincristine Small molecule 1 mg —
Background Vincristine Small molecule 1.4 mg/m2 —
Background Zuberitamab Monoclonal antibody 375 mg/m2 Intravenous

Indications

MCD diffuse large B-cell lymphoma