Combining orelabrutinib with R-CHOP for treating mantle cell lymphoma

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

This study is testing if adding a new drug called orelabrutinib to the standard R-CHOP treatment can help people who are newly diagnosed with mantle cell lymphoma do better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 356 (estimated)
• Ages: 60 Years to 80 Years
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry-sponsored)
• Drugs / interventions: orelabrutinib
• Locations: 22 sites (Hefei, Anhui and 21 other locations)
• Trial ID: NCT05051891 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of orelabrutinib when used in combination with the standard R-CHOP regimen compared to R-CHOP alone in patients who are newly diagnosed with mantle cell lymphoma. The study aims to determine if the addition of orelabrutinib can improve treatment outcomes for these patients. Participants will be randomly assigned to receive either the combination therapy or the standard treatment. The trial is being conducted across multiple centers to gather diverse data on its efficacy.

Who should consider this trial

Good fit: Ideal candidates are patients aged 60 to 80 with newly diagnosed mantle cell lymphoma who are not eligible for autologous stem cell transplantation.

Not a fit: Patients with uncontrolled cardiovascular diseases or significant mental impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with treatment-naïve mantle cell lymphoma.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in hematological malignancies, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. 65 \< age \<80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator
2. Histopathological confirmed MCL and either expression of cyclin D1 or t (11;14) chromosomal translocation (in association with CD20). The verification will be based on central review of the local pathology report.
3. No previous systemic treatment for MCL.
4. ECOG physical strength score is 0-2.
5. Expected survival time \>6 months.
6. Voluntary written informed consent prior to screening.

Exclusion Criteria:

1. Uncontrolled or significant cardiovascular diseases
2. History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment.
3. Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance;
4. Pregnant or breastfeeding women and those who do not agree to take contraceptive measures.
5. Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Hefei, Anhui and 21 other locations

• Anhui Province Cancer Hospital — Hefei, Anhui, China (Not_yet_recruiting)
• Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)
• Tumor in Hunan Province — Hunan, Changsha, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Not_yet_recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Guangzhou First People's Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Henan Tumor Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Wuhan Union Hospital — Wuhan, Hubei, China (Not_yet_recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• The First Hospital of China Medical University — Shenyang, Liaojing, China (Not_yet_recruiting)
• The First Affiliated Hospital of Guangxi Medical University — Guangxi, Nanning, China (Not_yet_recruiting)
• Shandong Provincial Hospital — Jinan, Shandong, China (Not_yet_recruiting)
• West China Hospital,Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• Hospital of Hematology, Chinese Academy of Medical Sciences — Tianjin, Tianjin, China (Not_yet_recruiting)
• Tianjin Cancer Hospital — Tianjin, Tianjin, China (Not_yet_recruiting)
• he First Affiliated Hospital of Zhengjiang University — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: April Huang

Conditions Treatment-naїve Mantle Cell Lymphoma