Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma

Phase 3

Recruiting

• Conditions: Relapsed/Refractory Marginal Zone Lymphoma
• Interventions: Drug: Orelabrutinib; Drug: Lenalidomide; Drug: Rituximab; Drug: Orelabrutinib Placebo

• Registration Number: NCT06082102
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Brief Summary

Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed/Refractory Marginal Zone Lymphoma

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-08
• Study First Submitted QC: 2023-10-08
• Study First Posted: 2023-10-13
• Study Start: 2023-12-19
• Status Verified: 2024-08
• Last Update Submitted: 2025-08-15
• Last Update Posted: 2025-08-20
• Primary Completion: 2028-08-31
• Study Completion: 2030-02-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 324

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Orelabrutinib Placebo	-
Orelabrutinib	Orelabrutinib	-
Orelabrutinib	Rituximab	-
Comparator	Lenalidomide	-
Comparator	Rituximab	-
Orelabrutinib	Orelabrutinib	-
Orelabrutinib	Lenalidomide	-
Placebo	Lenalidomide	-
Orelabrutinib	Rituximab	-
Placebo	Rituximab	-

Primary Outcome Measures

Name	Time	Method
IRC-assessed PFS	Through study completion, an average of 5 year.

Trial Locations

Locations (39)

Anqing Municipal Hospital; 🇨🇳 Anqing, Auhui, China

The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Auhui, China

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Tongren Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Henan Provincial Peoples Hospital; 🇨🇳 Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

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