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Orelabrutinib

Generic Name
Orelabrutinib
Drug Type
Small Molecule
Chemical Formula
C26H25N3O3
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。

Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma

Phase 3
Recruiting
Conditions
Primary Central Nervous System Lymphoma
Interventions
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
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

DDI Study of Orelabrutinib

Phase 1
Completed
Conditions
Healthy Person
Interventions
First Posted Date
2022-04-07
Last Posted Date
2022-07-06
Lead Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Target Recruit Count
36
Registration Number
NCT05316857
Locations
🇨🇳

The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

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

Not Applicable
Conditions
Neuromyelitis Optica Spectrum Disorder
Interventions
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 Plus R-CHOP in Treatment-naïve Patients With MCD Subtype Diffuse Large B-cell Lymphoma

Phase 3
Recruiting
Conditions
Diffuse Large B Cell Lymphoma (DLBCL)
Interventions
Drug: Placebo + R-CHOP
First Posted Date
2022-02-10
Last Posted Date
2024-02-07
Lead Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Target Recruit Count
150
Registration Number
NCT05234684
Locations
🇨🇳

PEKING University SHENZHEN Hospital, Shenzhen, Guangdong, China

🇨🇳

Sun Yat-sen University Cancer Center Internal medicine department, Guandong, Guangzhou, China

🇨🇳

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

and more 41 locations

Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma

Phase 2
Recruiting
Conditions
Central Nervous System Lymphoma
Interventions
First Posted Date
2022-01-26
Last Posted Date
2025-04-23
Lead Sponsor
Henan Cancer Hospital
Target Recruit Count
30
Registration Number
NCT05209620
Locations
🇨🇳

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university, Zhengzhou, Henan, China

A Study of Orelabrutinib in Patients With ITP

Phase 1
Conditions
Immune Thrombocytopenia
Interventions
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 Study of OLR in First-line Treatment of Mantle Cell Lymphoma

Phase 2
Conditions
Mantle Cell Lymphoma
Interventions
First Posted Date
2021-10-13
Last Posted Date
2021-11-11
Lead Sponsor
Tianjin Medical University Cancer Institute and Hospital
Target Recruit Count
29
Registration Number
NCT05076097
Locations
🇨🇳

Tianjin Medical University Cancer Insititute & Hospital, Tianjin, Tianjin, China

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

Phase 3
Recruiting
Conditions
Treatment-naїve Mantle Cell Lymphoma
Interventions
First Posted Date
2021-09-21
Last Posted Date
2022-10-12
Lead Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Target Recruit Count
356
Registration Number
NCT05051891
Locations
🇨🇳

The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China

🇨🇳

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

🇨🇳

Guangzhou First People's Hospital, Guangzhou, Guangdong, China

and more 19 locations

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

Phase 1
Active, not recruiting
Conditions
Primary Central Nervous System Lymphoma
Interventions
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

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