Combining orelabrutinib with R-CHOP for treating a specific type of lymphoma

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP Versus Placebo Plus R-CHOP in Treatment-naïve Patients With MCD Subtype DLBCL

This study is testing if adding a new drug called orelabrutinib to the standard R-CHOP treatment can help people with a specific type of lymphoma feel better and have better results.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry-sponsored)
• Drugs / interventions: rituximab, Chemotherapy, immunotherapy, orelabrutinib
• Locations: 44 sites (Bengbu, Anhui and 43 other locations)
• Trial ID: NCT05234684 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of orelabrutinib when used alongside the R-CHOP regimen in patients who have not previously received treatment for the MCD subtype of diffuse large B-cell lymphoma (DLBCL). Participants will be randomly assigned to receive either the combination of orelabrutinib and R-CHOP or a placebo with R-CHOP. The study aims to determine if the addition of orelabrutinib improves outcomes compared to standard treatment alone. It includes patients aged 18 to 80 with confirmed DLBCL and specific clinical criteria.

Who should consider this trial

Good fit: Ideal candidates are treatment-naïve adults aged 18 to 80 with histologically confirmed MCD subtype DLBCL.

Not a fit: Patients with a history of other active malignancies, central nervous system involvement, or transformed lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective option for patients with MCD subtype DLBCL, potentially improving survival rates.

How similar studies have performed: Other studies have shown promise with similar combinations of targeted therapies and chemotherapy in treating DLBCL, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Men and women between 18 and 80 years old
2. Treatment-naive patients
3. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) and CD20 positive.
4. Provide FFPE slices of past or fresh tumor biopsy tissue.
5. At least one measurable lesion.
6. Lymphoma International Prognostic Score (IPI) ≥ 2.
7. Ann Arbor stage II-IV, or stage I with bulky lesion (diameter \> 7.5 cm）
8. ECOG PS score of 0-2
9. Subjects who in line with the testing standard of the clinical trial laboratory.
10. Life expectancy ≥ 6 months.
11. Able to provide signed written informed consent.

Exclusion Criteria:

1. History of other active malignancies within 5 years of study entry, unless cured without evidence of relapse or metastasis
2. Lymphoma involving the central nervous system or leptomeningeal metastasis.
3. Transformed lymphoma, that is transformed from other types of lymphoma.
4. Primary mediastinal large B-cell lymphoma.
5. History of stroke or intracranial hemorrhage within 6 months before screening.
6. Co-morbidity of uncontrolled or significant cardiovascular disease, significant impaired lung function, significant gastrointestinal abnormalities, uncontrolled infections (including HBV, HCV, HIV/AIDS and tuberculosis), or active autoimmune disease.
7. Active bleeding within 2 months before screening, or a clear bleeding tendency determined by the investigator; a history of deep vein thrombosis or pulmonary embolism.
8. Previous history of surgeries (major 4 weeks and minor 2 weeks prior screening) , organ transplant or hematopoietic stem cell transplantation, or progressive multifocal leukoencephalopathy (PML).
9. Administer live and attenuated vaccines (semi-inactivated) within 28 days prior to first receiving the test drug.
10. Planned stem cell transplant during the experimental treatment are excluded.
11. Chemotherapy, immunotherapy, targeted therapy, radiotherapy, or traditional Chinese medicine with anti-tumor effects for the purpose of anti-tumor therapy within 4 weeks before starting to take the experimental drug. Excluding short-term emergency use of corticosteroids before treatment.
12. Current diagnosis of any mental or cognitive impairment, drug abuse, or alcohol abuse.
13. Pregnant, lactating women, or women at childbearing ages who will not use contraception during the study up to 12 months after the last dose of rituximab or 180 days after the last dose of study drug
14. The last use of strong CYP3A inhibitor or strong CYP3A inducer is less than 5 halflivesfrom the first trial drug, or the drug or food with moderate and strong CYP3A inhibitory effect or strong CYP3A induction effect is planned to be taken at the same time during this study.
15. Any serious medical condition that, in the investigator's opinion, would put the subject at unacceptable risk and/or would prevent the subject from signing the informed consent form. In the opinion of the investigator, the subject's participation in the study would be at unacceptable risk.

Where this trial is running

Bengbu, Anhui and 43 other locations

• The first affiliated hospital of bengbu medical college — Bengbu, Anhui, China (Recruiting)
• Anhui Provincal Cancer Hospital — Hefei, Anhui, China (Recruiting)
• Beijing Hospital — Beijing, Beijing, China (Recruiting)
• Chongqing University Cancer Hospital — Chongqing, Chongqing, China (Recruiting)
• The Southwest Hospital of AMU — Chongqing, Chongqing, China (Recruiting)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
• The First Affiliated Hospital Of XIAMEN University — Xiamen, Fujian, China (Recruiting)
• Gansu Provincial Cancer Hospital — Lanzhou, Gansu, China (Recruiting)
• The First People's Hospital of Foshan — Foshan, Guangdong, China (Recruiting)
• Guangdong General Hospital — Guangzhou, Guangdong, China (Recruiting)
• ZhuJiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• PEKING University SHENZHEN Hospital — Shenzhen, Guangdong, China (Recruiting)
• Sun Yat-sen University Cancer Center Internal medicine department — Guandong, Guangzhou, China (Recruiting)
• Affiliated Hospital of Hebei University — Baoding, Hebei, China (Recruiting)
• The Second Hospital of Hebei Medical University — Shijia Zhuang, Hebei, China (Recruiting)
• The First Affiliated Hospital of Henan University of science and Technology — Luoyang, Henan, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• Chenzhou first people's Hospital — Chenzhou, Hunan, China (Recruiting)
• The Affiliated Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)
• Wuxi People's Hospital — Wuxi, Jiangsu, China (Recruiting)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Recruiting)
• The First Affiliated Hospital Of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• The Second Hospital of Dalian Medical University — Dalian, Liaoning, China (Recruiting)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• Qilu Hospital Of Shandong University — Jinan, Shandong, China (Recruiting)
• Provincial Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (Recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
• Shanghai Changzheng Hospital — Shanghai, Shanghai, China (Active_not_recruiting)
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
• Shanghai 6th People's Hospital — Shanghai, Shanghai, China (Active_not_recruiting)
• The first Affiliated Hospital Of Xi'an Jiaotong University — Xi'an, Shanxi, China (Active_not_recruiting)
• The Second Affiliated Hospital Of Xi'an Jiaotong University — Xi'an, Shanxi, China (Recruiting)
• West China Hospital Sichuan University — Chengdu, Sichuan, China (Active_not_recruiting)
• Tianjin Cancer Hospital — Tianjin, Tianjin, China (Recruiting)
• Affiliated Cancer Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Recruiting)
• The first affiliated Hospital Zhejiang University School Of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Sir Run Run Shaw Hospital Zhejiang University School Of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Shaoxing People's Hospital — Shaoxing, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Weili Zhao — Ruijin Hospital
• Study coordinator: Weili Zhao

Conditions Diffuse Large B Cell Lymphoma