MedPath

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。

A Retrospective Study of Newly-diagnosed PCNSL Treated With a Methotrexate (MTX) and Orelabrutinib-based Regimen

Active, not recruiting
Conditions
Primary Central Nervous System Lymphoma
Interventions
First Posted Date
2023-11-03
Last Posted Date
2023-11-03
Lead Sponsor
Huashan Hospital
Target Recruit Count
80
Registration Number
NCT06115824
Locations
🇨🇳

Department of Hematology, Huashan Hospital, Fudan University, Shanghai, China

Efficacy and Safety of Orelabrutinib Plus Lenalidomide and Rituximab (R2) Compared to Placebo Plus R2 in r/r Marginal Zone Lymphoma

Phase 3
Recruiting
Conditions
Relapsed/Refractory Marginal Zone Lymphoma
Interventions
First Posted Date
2023-10-13
Last Posted Date
2024-08-20
Lead Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Target Recruit Count
324
Registration Number
NCT06082102
Locations
🇨🇳

The First Affiliated Hospital of Bengbu Medical College, Bengbu, Auhui, China

🇨🇳

Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing, China

🇨🇳

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

and more 17 locations

An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL

Not yet recruiting
Conditions
Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type
Interventions
First Posted Date
2023-08-29
Last Posted Date
2023-08-29
Lead Sponsor
The First Affiliated Hospital with Nanjing Medical University
Target Recruit Count
81
Registration Number
NCT06015464
Locations
🇨🇳

Hematological Department, People's Hospital of Jiangsu Province, Nanjing, Jiangsu, China

Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia

Phase 3
Recruiting
Conditions
Chronic Primary Immune Thrombocytopenia (ITP)
Interventions
Drug: Placebo
First Posted Date
2023-08-22
Last Posted Date
2024-05-13
Lead Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Target Recruit Count
195
Registration Number
NCT06004856
Locations
🇨🇳

The first affiliated hospital of bengbu medical college, Bengbu, Anhui, China

🇨🇳

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

🇨🇳

Beijing CHAO-YANG Hospital Capital Medcal University, Beijing, Beijing, China

and more 42 locations

Evaluating Different Doses of Orelabrutinib in MCL

Phase 2
Recruiting
Conditions
Mantle Cell Lymphoma
Interventions
First Posted Date
2023-08-07
Last Posted Date
2023-10-25
Lead Sponsor
InnoCare Pharma Inc.
Target Recruit Count
40
Registration Number
NCT05978739
Locations
🇨🇳

The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China

🇨🇳

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

🇨🇳

Peking University Third Hospital, Beijing, Beijing, China

and more 17 locations

Orelabrutinib Combined With Rituximab and Chemotherapy for Relapsed/Refractory B-Cell Lymphoma Patients With Central Nervous System Involvement

Phase 2
Recruiting
Conditions
CNS Lymphoma
Interventions
First Posted Date
2023-07-03
Last Posted Date
2023-09-05
Lead Sponsor
Ruijin Hospital
Target Recruit Count
25
Registration Number
NCT05926427
Locations
🇨🇳

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China

Phase IV Observational Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Cell Lymphoma

Recruiting
Conditions
CLL/SLL
First Posted Date
2023-06-27
Last Posted Date
2023-06-27
Lead Sponsor
Wang Xin
Target Recruit Count
20
Registration Number
NCT05920668
Locations
🇨🇳

Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China

Clinical Study of Orelabrutinib Combined With BG Regimen First-line Treatment of CLL/SLL

Phase 2
Not yet recruiting
Conditions
CLL/SLL
Interventions
First Posted Date
2023-06-26
Last Posted Date
2023-06-26
Lead Sponsor
Nanfang Hospital, Southern Medical University
Target Recruit Count
24
Registration Number
NCT05918276
Locations
🇨🇳

Hunan Cancer Hospital, Changsha, Hunan, China

🇨🇳

The Central Hospital Of Wuan, Wuhan, Hubei, China

Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients

Not Applicable
Recruiting
Conditions
Diffuse Large B Cell Lymphoma
Interventions
Drug: Pro-miniCHOP-like regimen
Drug: R-miniCHOP-like regimen
First Posted Date
2023-04-12
Last Posted Date
2023-04-20
Lead Sponsor
The First Affiliated Hospital of Soochow University
Target Recruit Count
35
Registration Number
NCT05809180
Locations
🇨🇳

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

R-MINE+X in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Not Applicable
Not yet recruiting
Conditions
Diffuse Large B-cell Lymphoma
Interventions
First Posted Date
2023-03-27
Last Posted Date
2023-03-27
Lead Sponsor
The First Affiliated Hospital with Nanjing Medical University
Target Recruit Count
60
Registration Number
NCT05784987
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