25 recruiting, 18 unknown, 9 not yet recruiting, 4 active not recruiting. 59 Phase 2, 5 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 59 | Recruiting 25, Unknown 18, Not yet recruiting 9, Active not recruiting 4, Completed 3 |
| Phase 1 | 5 | Unknown 3, Active not recruiting 1, Completed 1 |
| Phase 3 | 2 | Recruiting 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Orelabrutinib Combined With Obinutuzumab and Short-Course Venetoclax in Patients With Treatment-Naïve Mantle Cell Lymphoma (MCL) Orelabrutinib, Obinutuzumab, Venetoclax - Mantle Cell Lymphoma (MCL) | Phase 2 | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 39 | 2026-07-15 | 2026-07-22 |
| Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma R-CHOP+Orelabrutinib, POLA-R-CHP+orelabrutinib, R-miniCHOP +orelabrutinib - DLBCL - Diffuse Large B Cell Lymphoma | Phase 2 | Not yet recruiting | Ou Bai, MD/PHD | 66 | 2026-06-16 | 2026-07-01 |
| Ultra-low-dose Radiation Therapy Followed by Orelabrutinib as First-line Treatment for Stage Ⅰ-Ⅱ MALT Lymphoma Orelabrutinib, Ultra-low-dose Radiation Therapy - MALT Lymphoma | Phase 2 | Recruiting | Zhejiang Cancer Hospital | 60 | 2026-04-16 | 2026-05-11 |
| A Exploratory Study on Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide Orelabrutinib, Tafasitamab, Lenalidomide - Follicular Lymphoma | Phase 2 | Not yet recruiting | Institute of Hematology & Blood Diseases Hospital, China | 27 | 2026-04-15 | 2026-05-14 |
| Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy Orelabrutinib, Romiplostim N01 - Primary Immune Thrombocytopenia (ITP) | Phase 2 | Not yet recruiting | Peking Union Medical College Hospital | 28 | 2026-04-01 | 2026-02-10 |
| PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL. PD -1/PD-L1 monoclonal antibody, Rituximab (R), Methotrexate - Primary Central Nervous System Lymphoma (PCNSL), Secondary Central Nervous System Lymphoma (SCNSL) | Phase 2 | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 50 | 2026-02-07 | 2026-02-13 |
| Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL Orelabrutinib - Marginal Zone Lymphoma | Phase 2 | Recruiting | Institute of Hematology & Blood Diseases Hospital, China | 30 | 2026-01-05 | 2026-03-02 |
| Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation POLA-R-CHP, Orelabrutinib - Diffuse Large B-Cell Lymphoma (DLBCL) | Phase 2 | Recruiting | The First Affiliated Hospital of Soochow University | 35 | 2026-01-01 | 2026-03-30 |
| Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy Venetoclax combined with Ibrutinib, Venetoclax combined with Zanubrutinib, Venetoclax combined with Acalabrutinib - Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) | Phase 2 | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 79 | 2025-12-01 | 2025-11-25 |
| Treatment of Orelabrutinib+Hi-CVP Regimen for Previously Untreated MZL Orelabrutinib, Zuberitamab, Cyclophosphamide - Marginal Zone Lymphoma(MZL) | Phase 2 | Active not recruiting | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 65 | 2025-10-01 | 2026-04-02 |
| Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL Teniposide, Orelabrutinib, MTX - Primary Central Nervous System Lymphoma | Phase 2 / Phase 3 | Recruiting | Huashan Hospital | 215 | 2025-10-01 | 2026-08-19 |
| Chemotherapy Combined With Targeted Therapy as First-line Treatment for Mantle Cell Lymphoma Based on MRD and PET-CT Assessment Bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclonal antibody - Mantle Cell Lymphoma | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 45 | 2025-10-01 | 2025-10-03 |
| Orelabrutinib Plus Low-Dose Radiotherapy Or Rituximab For Ocular Adnexal MALT Lymphoma Orelabrutinib (ICP-022), radiotherapy, Rituximab (R) - Marginal Zone Lymphoma of Ocular Adnexal, Marginal Zone Lymphoma(MZL) | Phase 2 | Active not recruiting | Second Affiliated Hospital, Zhejiang University, School of Medicine | 39 | 2025-09-19 | 2025-11-25 |
| Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease Orelabrutinib, Rituximab (R), Lisaftoclax (APG-2575) - Mantle Cell Lymphoma (MCL) | Phase 2 | Recruiting | Ruijin Hospital | 25 | 2025-09-10 | 2026-07-28 |
| Orelabrutinib Combined With Zebetuzumab and Lenalidomide for the Treatment of Newly Diagnosed MZL Orelabrutinib, Zebetuzumab, Lenalidomide - Marginal Zone Lymphoma(MZL) | Phase 2 | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 169 | 2025-08-14 | 2025-10-06 |
| Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment Orelabrutinib, Rituximab (R), BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) - Mantle Cell Lymphoma (MCL) | Phase 2 | Recruiting | Ruijin Hospital | 45 | 2025-07-01 | 2025-09-30 |
| Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL Orelabrutinib, Rituximab, Lenalidomide - Marginal Zone Lymphoma(MZL) | Phase 2 | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 50 | 2025-04-01 | 2026-03-04 |
| Methotrexate or Thiotepa Combined With R-CHOP and Orelabrutinib in CNSL Patients Orelabrutinib, RCHOP+MTX or Thiotepa - CNS Lymphoma | Phase 2 | Not yet recruiting | Ruijin Hospital | 23 | 2025-04-01 | 2025-03-30 |
| MZL-IPI Risk-adapted Targeted Therapy in Untreated MZL Obinutuzumab and Orelabrutinib, Obinutuzumab, Orelabrutinib and Lenalidomide, Orelabrutinib - Marginal Zone Lymphoma(MZL) | Phase 2 | Recruiting | Ruijin Hospital | 145 | 2025-01-23 | 2026-03-24 |
| CR-CHOP+X in Previously Untreated DEL CR-CHOP+PD1 inhibitor, CR-CHOP + Orelabrutinib, CR-CHOP + decitabine - DLBCL | Phase 2 | Recruiting | Ruijin Hospital | 49 | 2024-12-10 | 2024-12-30 |
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Lymphoma, B-Cell, Marginal Zone (12) · Lymphoma, Mantle-Cell (7) · Lymphoma, Large B-Cell, Diffuse (5) · Purpura, Thrombocytopenic, Idiopathic (4) · Recurrence (3) · Leukemia, Lymphocytic, Chronic, B-Cell (2) · Lupus Erythematosus, Systemic (2) · Lymphoma (2) · Lymphoma, Follicular (2) · Bronchiolitis Obliterans Syndrome (1) · Dendritic Cell Sarcoma, Interdigitating (1) · Hematologic Neoplasms (1) · Lymphoma, B-Cell (1) · Lymphoma, Non-Hodgkin (1) · Multiple Sclerosis, Relapsing-Remitting (1)
Beijing InnoCare Pharma Tech Co., Ltd. (7) · Ruijin Hospital (7) · The First Affiliated Hospital with Nanjing Medical University (7) · Peking Union Medical College Hospital (4) · Institute of Hematology & Blood Diseases Hospital, China (3) · Second Affiliated Hospital, Zhejiang University, School of Medicine (3) · Sun Yat-sen University (3) · Fei Li (2) · Fudan University (2) · Peking University People's Hospital (2) · The First Affiliated Hospital of Soochow University (2) · Tianjin Medical University Cancer Institute and Hospital (2) · Affiliated Hospital of Nantong University (1) · Affiliated Hospital to Academy of Military Medical Sciences (1) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (1)
China (52) · Poland (2) · Ukraine (2) · United States (2) · Israel (1)
Fei Li, professor (1) · Huilai Zhang, PHD (1) · Jianyong Li, Phd, MD (1) · Jun Shi (1) · Liang Wang (1) · Ming Hou, MD,PhD (1) · Qingqing Cai (1) · Rong Tao (1) · Ru Feng, Master (1) · Shaoying Chen (1) · Shenmiao Yang (1) · Tienan Zhu, M.D. (1) · Tong Chen (1) · Xiao-Hui Zhang, MD (1)
PMID 40550489, PMID 26096944, PMID 38546375, PMID 40425940, PMID 42214214, PMID 42630801