Clinical trial NCT06082102: Efficacy and Safety of Orelabrutinib Plus Lenalidomide and Rituximab (R2) Compared to Placebo Plus R2 in r/r Marginal Zone Lymphoma
Official title: A Randomized, Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Orelabrutinib Plus Lenalidomide and Rituximab (R2) Versus Placebo Plus R2 in Relapsed/Refractory Marginal Zone Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Relapsed/Refractory Marginal Zone Lymphoma
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-13
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the Efficacy and Safety of Orelabrutinib Plus Lenalidomide and Rituximab (R2) Versus Placebo Plus R2 in Relapsed/Refractory Marginal Zone Lymphoma.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years and ≤ 80 years, either sex.
2. Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
3. At least one and no more than 3 prior lines of systemic therapy (CD20 targeted therapy included in at least one line).
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.
3. Prior treatment with any types of BTK inhibitor.
4. Prior allogeneic hematopoietic stem cell transplantation (Allo-HSCT), or Autologous hematopoietic stem cell transplantation (ASCT) within 6 months prior to the first dose of the study treatment; or prior CAR-T cell therapy.
5. Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.

Primary outcomes:
measure: IRC-assessed PFS
timeFrame: Through study completion, an average of 5 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Anqing
country: China
facility: Anqing Municipal Hospital
state: Auhui
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Auhui
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial Peoples Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: The first Hospital of China Medical University
state: Liaoning
city: Qingdao
country: China
facility: The Affiliated Hospital Of Qingdao University
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital）
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: