9 recruiting, 4 unknown, 3 not yet recruiting, 1 completed. 17 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 17 | Recruiting 9, Unknown 4, Not yet recruiting 3, Completed 1 |
| Phase 2 | 2 | Recruiting 2 |
Follow orelabrutinib: new trials by email Literature Review of orelabrutinib trials Research Report on orelabrutinib
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 |
|---|---|---|---|---|---|---|
| A Phase 3 Study to Compare the Efficacy of ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL). ICP-248, Pirtobrutinib, Orelabrutinib - Relapsed or Refractory Mantle Cell Lymphoma (MCL) | Phase 3 | Not yet recruiting | Beijing InnoCare Pharma Tech Co., Ltd. | 280 | 2026-10-01 | 2026-08-25 |
| Orelabrutinib Plus ICP 248 vs Orelabrutinib for Relapsed/Refractory Marginal Zone Lymphoma Orelabrutinib, ICP-248 - Relapsed/Refractory Marginal Zone Lymphoma (MZL) | Phase 3 | Not yet recruiting | Beijing InnoCare Pharma Tech Co., Ltd. | 292 | 2026-10-01 | 2026-10-27 |
| A Multicenter, Prospective, Open-Label, Randomized Controlled Clinical Study of Orelabrutinib Combined With Obinutuzumab and Lenalidomide Versus Obinutuzumab Plus Chemotherapy for Treatment-Naive Follicular Lymphoma Orelabrutinib, obinutuzumab, Lenalidomide - Follicular Lymphoma ( FL) | Phase 3 | Not yet recruiting | Ruijin Hospital | 652 | 2026-07-01 | 2026-07-22 |
| High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia High-Dose Dexamethasone Combined with Orelabrutinib, High-Dose Dexamethasone Combined with Placebo - Primary Immune Thrombocytopenia (ITP) | Phase 3 | Recruiting | Shandong University | 86 | 2026-04-08 | 2026-04-30 |
| A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis Orelabrutinib, Placebo - Multiple Sclerosis (MS) Primary Progressive | Phase 3 | Recruiting | Zenas BioPharma (USA), LLC | 705 | 2026-03-23 | 2026-10-27 |
| A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis Orelabrutinib, Placebo - Secondary Progressive Multiple Sclerosis | Phase 3 | Recruiting | Zenas BioPharma (USA), LLC | 990 | 2026-03-23 | 2026-10-27 |
| A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma Rocbrutinib, Ibrutinib, Acalabrutinib - Mantle Cell Lymphoma | Phase 3 | Recruiting | Guangzhou Lupeng Pharmaceutical Company LTD. | 394 | 2026-02-05 | 2026-02-06 |
| 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 |
| Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment Orelabrutinib, Bendamustine, Rituximab - Mantle Cell Lymphoma (MCL) | Phase 3 | Recruiting | Ruijin Hospital | 78 | 2024-07-10 | 2024-07-11 |
| A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL Orelabrutinib, Bendamustine Injection, Rituximab - Mantle Cell Lymphoma | Phase 3 | Recruiting | InnoCare Pharma Inc. | 476 | 2024-05-29 | 2024-12-27 |
| ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03) ICP-248, Orelabrutinib - Hematologic Malignancies | Phase 2 / Phase 3 | Recruiting | Beijing InnoCare Pharma Tech Co., Ltd. | 226 | 2024-05-15 | 2025-11-21 |
| Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma Orelabrutinib, Rituximab, Lenalidomide - Relapsed/Refractory Marginal Zone Lymphoma | Phase 3 | Recruiting | Beijing InnoCare Pharma Tech Co., Ltd. | 324 | 2023-12-19 | 2025-09-15 |
| Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia Orelabrutinib, Placebo - Chronic Primary Immune Thrombocytopenia (ITP) | Phase 3 | Unknown | Beijing InnoCare Pharma Tech Co., Ltd. | 195 | 2023-10-26 | 2024-05-13 |
| A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With MCD Subtype Diffuse Large B-cell Lymphoma Orelabrutinib + R-CHOP, Placebo + R-CHOP - Diffuse Large B Cell Lymphoma (DLBCL) | Phase 3 | Unknown | Beijing InnoCare Pharma Tech Co., Ltd. | 150 | 2022-11-02 | 2024-02-07 |
| Genotype-guided Treatment in DLBCL Rituximab, Cyclophosphamide, Doxorubicin - Diffuse Large B Cell Lymphoma | Phase 3 | Unknown | Ruijin Hospital | 1100 | 2022-06-01 | 2023-03-24 |
| A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma Orelabrutinib and R-CHOP, R-CHOP - Treatment-naїve Mantle Cell Lymphoma | Phase 3 | Completed | Beijing InnoCare Pharma Tech Co., Ltd. | 3 | 2021-12-22 | 2026-03-31 |
| Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma Orelabrutinib - Primary Central Nervous System Lymphoma | Phase 3 | Unknown | Ruijin Hospital | 174 | 2021-12-01 | 2022-04-19 |
Lymphoma, Mantle-Cell (4) · Lymphoma, B-Cell, Marginal Zone (2) · Lymphoma, Large B-Cell, Diffuse (2) · Multiple Sclerosis, Chronic Progressive (2) · Hematologic Neoplasms (1) · Lymphoma, Follicular (1) · Purpura, Thrombocytopenic, Idiopathic (1) · Recurrence (1)
Beijing InnoCare Pharma Tech Co., Ltd. (7) · Ruijin Hospital (4) · Zenas BioPharma (USA), LLC (2) · Guangzhou Lupeng Pharmaceutical Company LTD. (1) · Huashan Hospital (1) · InnoCare Pharma Inc. (1) · Shandong University (1)
China (15) · Bulgaria (2) · Croatia (2) · Czechia (2) · Estonia (2) · Georgia (2) · Italy (2) · Poland (2) · Puerto Rico (2) · Serbia (2) · Spain (2) · Ukraine (2) · United States (2) · Australia (1) · Germany (1)
Tong Chen (1) · Weili Zhao (1)