Orelabrutinib

Generic Name: Orelabrutinib

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₅N_₃O_₃

CAS Number: 1655504-04-3

Unique Ingredient Identifier: WJA5UO9E10

Background: Orelabrutinib is under investigation in clinical trial NCT04305197 (A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)).

Indication: ⑴既往至少接受过一种治疗的成人套细胞淋巴瘤（MCL）患者。

⑵既往至少接受过一种治疗的成人慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）患者。

Associated Conditions: -

Associated Therapies: -

Clinical Trials

Orelabrutinib Therapy in Patients With r/r B-cell Lymphoma Intolerant to Other Bruton Tyrosine Kinase Inhibitors

Recruiting

Conditions: B-cell Lymphoma

Interventions: Drug: Orelabrutinib

First Posted Date: 2022-08-10

Last Posted Date: 2023-10-26

Lead Sponsor: Peking University People's Hospital

Target Recruit Count: 30

Registration Number: NCT05495828

Locations: 🇨🇳
Deparment of Hematology, Peking University People's Hospital, Beijing, Beijing, China

A Study of Orelabrutinib in CLL/SLL Patients Who Are Slowly Responding to Ibrutinib

Phase 2

Recruiting

Conditions: CLL/SLL

Interventions: Drug: orelabrutinib

First Posted Date: 2022-08-08

Last Posted Date: 2023-10-26

Lead Sponsor: Peking University People's Hospital

Target Recruit Count: 30

Registration Number: NCT05491044

Locations: 🇨🇳
Department of Hematology, Peking University People's Hospital, Beijing, Beijing, China
🇨🇳
Peking University People's Hospital, Beijing, Beijing, China

Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL

Phase 2

Recruiting

Conditions: Primary Central Nervous System Lymphoma

Interventions: Drug: Orelabrutinib
Drug: Pomalidomide
Drug: Rituximab
Drug: Methotrexate

First Posted Date: 2022-05-25

Last Posted Date: 2022-05-25

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 50

Registration Number: NCT05390749

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, Beijing, China
🇨🇳
Sanbo Brain Hospital Capital Medical University, Beijing, Beijing, China
🇨🇳
Beijing TianTan Hospital, Beijing, Beijing, China

Genotype-guided Treatment in DLBCL

Phase 3

Recruiting

Conditions: Diffuse Large B Cell Lymphoma

Interventions: Drug: Rituximab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Drug: Orelabrutinib
Drug: Lenalidomide
Drug: Decitabine

First Posted Date: 2022-04-28

Last Posted Date: 2023-03-24

Lead Sponsor: Ruijin Hospital

Target Recruit Count: 1100

Registration Number: NCT05351346

Locations: 🇨🇳
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China

Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma

Phase 3

Recruiting

Conditions: Primary Central Nervous System Lymphoma

Interventions: Drug: Orelabrutinib

First Posted Date: 2022-04-19

Last Posted Date: 2022-04-19

Lead Sponsor: Ruijin Hospital

Target Recruit Count: 174

Registration Number: NCT05334238

Locations: 🇨🇳
Ruijin Hospital, Shanghai, Shanghai, China

Orelabrutinib and Obinutuzumab Plus FC Regimen in Treating Newly Diagnosed CLL/SLL

Phase 2

Recruiting

Conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Interventions: Drug: Orelabrutinib
Drug: Obinutuzumab
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2022-04-12

Last Posted Date: 2022-04-19

Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Target Recruit Count: 25

Registration Number: NCT05322733

Locations: 🇨🇳
Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjin, Jiangsu, China

A Study of Orelabrutinib in Patients With AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder

Not Applicable

Conditions: Neuromyelitis Optica Spectrum Disorder

Interventions: Drug: Orelabrutinib

First Posted Date: 2022-03-17

Last Posted Date: 2022-03-17

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 23

Registration Number: NCT05284175

Locations: 🇨🇳
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China

A Study of Orelabrutinib in Patients With ITP

Phase 1

Conditions: Immune Thrombocytopenia

Interventions: Drug: Orelabrutinib

First Posted Date: 2021-11-17

Last Posted Date: 2021-11-17

Lead Sponsor: Peking University People's Hospital

Target Recruit Count: 10

Registration Number: NCT05124028

Locations: 🇨🇳
Peking University Institute of Hematology, Beijing, Beijing, China

A Dose-escalating Pilot Study of Orelabrutinib for Newly-diagnosed PCNSL

Phase 1

Active, not recruiting

Conditions: Primary Central Nervous System Lymphoma

Interventions: Drug: Orelabrutinib
Drug: Rituximab
Drug: Methotrexate (MTX)
Drug: Dexamethasone

First Posted Date: 2021-09-05

Last Posted Date: 2024-10-18

Lead Sponsor: Huashan Hospital

Target Recruit Count: 15

Registration Number: NCT05036577

Locations: 🇨🇳
Department of Hematology, Huashan Hospital, Fudan University, Shanghai, Shanghai, China

Orelabrutinib in Combination With Thiotepa in Refractory and Relapsed Primary CNS Lymphoma

Phase 1

Conditions: PCNSL
Refractory and Relapsed Primary CNS Lymphoma
Non Hodgkin Lymphoma

Interventions: Drug: Orelabrutinib
Drug: Thiotepa

First Posted Date: 2021-08-26

Last Posted Date: 2021-08-26

Lead Sponsor: Huiqiang Huang

Target Recruit Count: 29

Registration Number: NCT05021770

Locations: 🇨🇳
Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

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