Inokai (orelabrutinib) / InnoCare, Biogen - LARVOL DELTA

Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy (clinicaltrials.gov) - P2 | N=79 | Recruiting | Sponsor: The First Affiliated Hospital with Nanjing Medical University

Monotherapy • New P2 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Novel Triplet Combination of Orelabrutinib, Lenalidomide, and Rituximab as Frontline Therapy for Mantle Cell Lymphoma: Final Results of POLARIS Multicenter Phase II Study (ICML 2025) - No abstract available

Clinical • P2 data • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

Orelabrutinib for the treatment of relapsed/refractory mantle cell lymphoma: efficacy and safety results from a global phase 1/2 study (ICML 2025) - No abstract available

Clinical • P1/2 data • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

The efficacy, safety and rationality of Orelabrutinib plus Obinutuzumab (O2) in systemic treatment-naïve marginal zone lymphoma: a prospective cohort study (ICML 2025) - No abstract available

Clinical • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Oncology

Orelabrutinib plus bendamustine-rituximab (OBR) versus bendamustine-rituximab (BR) in transplant-ineligible, intermediate- to high-risk mantle cell lymphoma (MCL) (ICML 2025) - No abstract available

Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

First-line R-MTO regimen (rituximab, methotrexate, thiotepa, and orelabrutinib) followed by autologous hematopoietic stem cell transplantation in PCNSL (ICML 2025) - No abstract available

Clinical • CNS Lymphoma • Lymphoma • Primary Central Nervous System Lymphoma

Orelabrutinib plus semustine, temozolomide and lenalidomide (BMeTL) regimen with sequential maintenance treatment in elderly or frail patients with CNSL: a phase II study (ICML 2025) - No abstract available

Clinical • P2 data • Lymphoma

The Efficacy and Safety of Orelabrutinib, Rituximab and High-Dose Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma: A Retrospective Study (ICML 2025) - No abstract available

Retrospective data • CNS Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma

Rituximab, high-dose methotrexate plus orelabrutinib as induction therapy in newly diagnosed primary central nervous system lymphoma (ICML 2025) - No abstract available

CNS Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma

Orelabrutinib plus rituximab and high-dose methotrexate in primary central nervous system diffused large B-cell lymphoma: a single-arm phase II study (ICML 2025) - No abstract available

P2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Phase I/II Study of Orelabrutinib Combined with Anti-PD-1 Antibody and Fotemustine for Patients with Newly Diagnosed Primary Central Nervous System Lymphoma (PCNSL) (ICML 2025) - No abstract available

Clinical • P1/2 data • CNS Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma

A Phase II Trial of Orelabrutinib Combined with Zuberitamab in Previously Untreated Marginal Zone Lymphoma: A Multicenter, Single-Arm Study (ZOOM Trial) (ICML 2025) - No abstract available

Clinical • P2 data • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Oncology

Phase II trial of Orelabrutinib, fludarabine, cyclophosphamide, and obinutuzumab (OFCG) for first-line treatment of chronic lymphocytic leukemia: the cwcll-001 trial (ICML 2025) - No abstract available

Clinical • P2 data • Hematological Malignancies • Lymphoma • Oncology

The Efficacy and Safety of Orelabrutinib‑Based Regimens in the Treatment of Marginal Zone Lymphoma: A Retrospective Real-World Study (ICML 2025) - No abstract available

Real-world • Real-world evidence • Retrospective data • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Oncology

Orelabrutinib combined with anti-CD20 monoclonal antibodies is highly effective and well tolerated as first-line therapy for marginal zone B cell lymphoma (ICML 2025) - No abstract available

Clinical • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Orelabrutinib-based regimens in chronic lymphocytic leukemia: a real-world study (ICML 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Lymphoma • Oncology

ORELABRUTINIB PLUS LENALIDOMIDE AND RITUXIMAB FOR THE TREATMENT OF ELDERLY UNFIT PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE-B CELL LYMPHOMA (ICML 2025) - No abstract available

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Efficacy and safety of orelabrutinib plus obinutuzumab and lenalidomide in previously untreated marginal zone lymphoma: a single-arm, multicenter, phase II study (ICML 2025) - No abstract available

Clinical • P2 data • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Oncology

Short-course immunochemotherapy followed by sequential orelabrutinib in patients with high-risk marginal zone lymphoma (ICML 2025) - No abstract available

Clinical • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Oncology

Phase II study of orelabrutinib plus obinutuzumab with or without chemotherapy for marginal zone lymphoma patients with high-risk recurrence factors (ICML 2025) - No abstract available

Clinical • P2 data • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Oncology

Indirect Comparisons of Efficacy of Zanubrutinib Versus Orelabrutinib in Patients with R/R MCL: An Extended Follow-up Analysis. (PubMed, Adv Ther) - "MAIC results demonstrated that zanubrutinib had significantly longer PFS compared with orelabrutinib in the treatment of patients with R/R MCL."

Journal • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

Prospective phase II trial of first-line rituximab, methotrexate, and orelabrutinib (R-MO) in primary central nervous system lymphoma. (PubMed, Blood Cancer J) - "The most common adverse events were neutropenia, lymphocytopenia, and infections, each occurring in 45.9% of patients. Overall, the addition of orelabrutinib to high-dose methotrexate and rituximab in newly diagnosed PCNSL patients has demonstrated promising outcomes and favorable safety profiles, advocating for the use of this combination therapy as a potential frontline treatment option for PCNSL."

Journal • P2 data • CNS Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • Transplantation

Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Henan Cancer Hospital | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial primary completion date • B Cell Lymphoma • CNS Lymphoma • Hematological Malignancies • Lymphoma • Oncology • Secondary Central Nervous System Lymphoma

InnoCare Announces Approval of Orelabrutinib for the First-line Treatment of CLL/SLL in China (Businesswire) - "InnoCare Pharma...announced today that its BTK inhibitor orelabrutinib received approval from the China National Medical Products Administration (NMPA) for the first-line treatment of patients with chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL). The approval of the first-line CLL/SLL treatment will enable orelabrutinib to benefit an even broader population of lymphoma patients."

China approval • Chronic Lymphocytic Leukemia • Small Lymphocytic Lymphoma

Multi center, prospective, single arm study of sequential treatment with ultra-low dose radiotherapy and obetinib for localized Lymphoma of extranodal margin of ocular adnexal mucosa associated lymphoid tissue (ChiCTR) - P=N/A | N=28 | Not yet recruiting | Sponsor: Army Medical Center of PLA; Army Medical Center of PLA

New trial • Extranodal Marginal Zone Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Oncology