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Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator |
| |
| Arm B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orelabrutinib | Drug | Eligible patients will receive Orelabrutinib orally as per the protocol,until disease progression or other reasons for treatment discontinuation,whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | 28 days | |
| Progression-free Survival (PFS) for Arm A vs. Arm B | Approximately 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexia Lu | Contact | 010-66609745 | CO_HGRAC@innocarepharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | China |
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| Bendamustine Injection | Drug | Eligible patients will receive Bendamustine by injection as per the protocol |
|
| Rituximab | Drug | Eligible patients will receive Rituximab by injection as per the protocol |
|
| Orelabrutinib Placebo | Drug | Eligible patients will receive Orelabrutinib Placebo orally as per the protocol |
|
| Peking University Third Hospital | Recruiting | Beijing | China |
|
| The First Affiliated Hospital of Bengbu Medical University | Recruiting | Bengbu | China |
|
| First Hospital of Jilin University | Not yet recruiting | Changchun | China |
|
| Hunan Cancer Hospital | Recruiting | Changsha | China |
|
| The First People's Hospital of Changzhou | Not yet recruiting | Changzhou | China |
|
| Sichuan Provincial People's Hospital | Recruiting | Chengdu | China |
|
| West China Hospital of Sichuan University | Not yet recruiting | Chengdu | China |
|
| Chongqinq Cancer Hospital | Recruiting | Chongqing | China |
|
| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | China |
|
| The second Hospital of Dalian Medical University | Not yet recruiting | Dalian | China |
|
| Fujing Cancer Hospital | Recruiting | Fuzhou | China |
|
| Union Hospital Affiliated to Fujian Medical University | Not yet recruiting | Fuzhou | China |
|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | China |
|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | China |
|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | China |
|
| Zhejiang University Medical School affiliated to the first Hospital | Recruiting | Hangzhou | China |
|
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | China |
|
| Cancer Hospital of Shandong First Medical University | Not yet recruiting | Jinan | China |
|
| Shandong Provincial Hospital | Not yet recruiting | Jinan | China |
|
| The First Affiliated Hospital of Ningbo University | Recruiting | Jinan | China |
|
| The First Affiliated Hospital of Henan University of Science & Technology | Not yet recruiting | Luoyang | China |
|
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | China |
|
| Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University | Not yet recruiting | Nanjing | China |
|
| Cancer Hospital Affiliated to Fudan University | Not yet recruiting | Shanghai | China |
|
| Huashan Hospital of Fudan University | Recruiting | Shanghai | China |
|
| Shengjing Hospital of China Medical University | Not yet recruiting | Shenyang | China |
|
| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | China |
|
| The Fourth Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | China |
|
| Shanxi Cancer Hospital | Not yet recruiting | Taiyuan | China |
|
| Tianjin Cancer Hospital | Recruiting | Tianjin | China |
|
| The Tumor Hospital Affiliated to Xinjiang Medical University | Recruiting | Ürümqi | China |
|
| Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and | Recruiting | Wuhan | China |
|
| Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and | Not yet recruiting | Wuhan | China |
|
| The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital) | Not yet recruiting | Xi'an | China |
|
| The Second Affiliated Hospital Of Xi'an Jiaotong University | Not yet recruiting | Xi'an | China |
|
| Yibin Second People's Hospital | Not yet recruiting | Yibin | China |
|
| Henan Cancer Hospital | Recruiting | Zhengzhou | China |
|
| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | China |
|
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000729508 | orelabrutinib |
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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