Combining Orelabrutinib with Lenalidomide and Rituximab for treating relapsed Marginal Zone Lymphoma

A Randomized, Controlled, Open-label, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Orelabrutinib Plus Rituximab Versus Lenalidomide Plus Rituximab in Relapsed/Refractory Marginal Zone Lymphoma

This study is testing if adding a new drug called Orelabrutinib to the standard treatment of Lenalidomide and Rituximab can help people with relapsed Marginal Zone Lymphoma feel better and improve their outcomes.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 324 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry-sponsored)
• Drugs / interventions: rituximab, Orelabrutinib
• Locations: 19 sites (Bengbu, Auhui and 18 other locations)
• Trial ID: NCT06082102 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a combination treatment involving Orelabrutinib, Lenalidomide, and Rituximab compared to a placebo with the same regimen in patients with relapsed or refractory Marginal Zone Lymphoma. The study aims to determine whether the addition of Orelabrutinib can improve treatment outcomes for patients who have not responded to previous therapies. Participants will be monitored for measurable lesions using advanced imaging techniques to assess the effectiveness of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with confirmed Marginal Zone Lymphoma who have received one to three prior lines of systemic therapy.

Not a fit: Patients who have previously been treated with BTK inhibitors or have undergone certain types of stem cell transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with relapsed or refractory Marginal Zone Lymphoma.

How similar studies have performed: Other studies have shown promising results with similar combinations of therapies in treating various forms of lymphoma, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years , either sex.
2. Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
3. Prior systemic therapy including at least one anti-CD20 monoclonal antibody-containing regimen is required, with the following specifications:

   For combination therapies: Minimum of 2 completed treatment cycles For anti-CD20 monotherapy: Minimum of 4 administered doses Progression during treatment waives cycle/dose requirements
4. Relapsed or refractory disease.
5. At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI).
6. ECOG performance status (PS) score of 0-2.

Exclusion Criteria:

1. Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment.
2. Administration of any other investigational product within 4 weeks prior to the first dose of the study treatment, or concurrent participation in another clinical trial.(Excluding patients who have discontinued treatment and are in long-term follow-up).
3. Prior treatment with any types of BTK inhibitor.
4. Patients refractory to lenalidomide plus rituximab (R2 regimen). Refractoriness is defined as either: Failure to achieve at least partial response (PR) after completing an adequate R2 treatment course (≥2 cycles at standard doses), OR Disease progression during R2 therapy or within 6 months after the last dose.
5. Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.

Where this trial is running

Bengbu, Auhui and 18 other locations

• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Auhui, China (Recruiting)
• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Tongren Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Guangdong Provincial Hospital of Chinese Medicine — Guangzhou, Guangdong, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Henan Provincial Peoples Hospital — Zhengzhou, Henan, China (Recruiting)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• Jiangxi Cancer Hospital — 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)
• The Affiliated Hospital Of Qingdao University — Qingdao, Shandong, China (Not_yet_recruiting)
• Yantai Yuhuangding Hospital — Yantai, Shandong, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
• The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital） — Xi’an, Shanxi, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Alexia Lu

Conditions Relapsed/Refractory Marginal Zone Lymphoma