Comparing Orelabrutinib with standard treatment for mantle cell lymphoma

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma

This study is testing if adding a new drug called Orelabrutinib to the standard treatment can help older patients with untreated mantle cell lymphoma feel better and improve their outcomes.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 476 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: InnoCare Pharma Inc. (Industry-sponsored)
• Drugs / interventions: rituximab, Orelabrutinib
• Locations: 39 sites (Beijing and 38 other locations)
• Trial ID: NCT06363994 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Orelabrutinib combined with bendamustine and rituximab compared to the standard treatment of bendamustine and rituximab alone in patients with previously untreated mantle cell lymphoma (MCL). The study aims to enroll patients aged 60 and older who are not candidates for stem cell transplantation. Participants will be assessed for measurable disease and must have a confirmed diagnosis of MCL. The trial is designed to provide insights into the potential benefits of Orelabrutinib in improving treatment outcomes for this patient population.

Who should consider this trial

Good fit: Ideal candidates are patients aged 60 and older with untreated mantle cell lymphoma who are not eligible for stem cell transplantation.

Not a fit: Patients with a history of other malignancies or significant gastrointestinal dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective option for patients with mantle cell lymphoma, potentially improving survival rates.

How similar studies have performed: Other studies have shown promise in using targeted therapies for mantle cell lymphoma, suggesting potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Beijing and 38 other locations

• 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)

Study contacts

• Study coordinator: Alexia Lu

Conditions Mantle Cell Lymphoma