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Clinical Trials in China / NCT06363994
Recruiting Phase 3

A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL

NCT06363994 · tracked via the Priya Life Science China tracker
Sponsor
InnoCare Pharma Inc.
Phase
Phase 3
Started
2024-05-29
Last updated
2024-12-27

Condition(s) studied

Mantle Cell Lymphoma

Investigational drug(s) / intervention(s)

OrelabrutinibBendamustine InjectionRituximabOrelabrutinib Placebo

Orelabrutinib: Eligible patients will receive Orelabrutinib orally as per the protocol,until disease progression or other reasons for treatment discontinuation,whichever comes first.

Bendamustine Injection: Eligible patients will receive Bendamustine by injection as per the protocol

Rituximab: Eligible patients will receive Rituximab by injection as per the protocol

Orelabrutinib Placebo: Eligible patients will receive Orelabrutinib Placebo orally as per the protocol

Study summary

Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)

Eligibility

Sex
ALL
Min age
60 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Subjects ≥ 65 of age, or ≥ 60 and \< 65 years old who are ineligible for stem cell transplant or have refused stem cell transplantation due to reason(s) including: Have not received prior systemic therapies for MCL. 2. Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator. 3. Histopathological confirmed MCL, expression of Cyclin D1 and/or t (11; 14) chromosomal translocation. Either fresh tissue or FFPE for diagnosis must be sent to central lab for final confirmation after randomization. 4. At least one measurable site of disease (the longest axis of the lymph node lesion is \> 1.5 cm, or the longest diameter of the extranodal lesion is \> 1.0 cm). 5. ECOG PS score of 0 to 2. Exclusion Criteria: 1. Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening. 2. Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy. 3. Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant. 4. Use of strong inhibitors or strong inducers of cytochrome P450 3A within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment; or plan to use strong inhibitors or strong inducers of CYP3A during the study. 5. Known central nervous system lymphoma.

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing China Recruiting
Peking University Third Hospital Beijing China Recruiting
The First Affiliated Hospital of Bengbu Medical University Bengbu China Recruiting
First Hospital of Jilin University Changchun China Not Yet Recruiting
Hunan Cancer Hospital Changsha China Recruiting
The First People's Hospital of Changzhou Changzhou China Not Yet Recruiting
Sichuan Provincial People's Hospital Chengdu China Recruiting
West China Hospital of Sichuan University Chengdu China Not Yet Recruiting
Chongqinq Cancer Hospital Chongqing China Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqing China Not Yet Recruiting
The second Hospital of Dalian Medical University Dalian China Not Yet Recruiting
Fujing Cancer Hospital Fuzhou China Recruiting
Union Hospital Affiliated to Fujian Medical University Fuzhou China Not Yet Recruiting
Guangdong Provincial People's Hospital Guangzhou China Recruiting
Sun Yat-sen University Cancer Center Guangzhou China Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou China Not Yet Recruiting
Zhejiang University Medical School affiliated to the first Hospital Hangzhou China Recruiting
The First Affiliated Hospital of Anhui Medical University Hefei China Recruiting
Cancer Hospital of Shandong First Medical University Jinan China Not Yet Recruiting
Shandong Provincial Hospital Jinan China Not Yet Recruiting
The First Affiliated Hospital of Ningbo University Jinan China Recruiting
The First Affiliated Hospital of Henan University of Science & Technology Luoyang China Not Yet Recruiting
The First Affiliated Hospital of Nanchang University Nanchang China Recruiting
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University Nanjing China Not Yet Recruiting
Cancer Hospital Affiliated to Fudan University Shanghai China Not Yet Recruiting
Huashan Hospital of Fudan University Shanghai China Recruiting
Shengjing Hospital of China Medical University Shenyang China Not Yet Recruiting
The First Affiliated Hospital of China Medical University Shenyang China Recruiting
The Fourth Hospital of Hebei Medical University Shijiazhuang China Not Yet Recruiting
Shanxi Cancer Hospital Taiyuan China Not Yet Recruiting
Tianjin Cancer Hospital Tianjin China Recruiting
The Tumor Hospital Affiliated to Xinjiang Medical University Ürümqi China Recruiting
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Wuhan China Recruiting
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Wuhan China Not Yet Recruiting
The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital) Xi'an China Not Yet Recruiting
The Second Affiliated Hospital Of Xi'an Jiaotong University Xi'an China Not Yet Recruiting
Yibin Second People's Hospital Yibin China Not Yet Recruiting
Henan Cancer Hospital Zhengzhou China Recruiting
Henan Provincial People's Hospital Zhengzhou China Not Yet Recruiting

On this site

📄 Rituxan (rituximab) drug profile →

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06363994 on ClinicalTrials.gov ↗ ← All trials in China