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Efficacy and Safety of Orelabrutinib Plus Lenalidomide and Rituximab (R2) Compared to Placebo Plus R2 in r/r Marginal Zone Lymphoma

Sponsor
Beijing InnoCare Pharma Tech Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06082102
Collaborator
(none)
324
Enrollment
11
Locations
2
Arms
76.1
Anticipated Duration (Months)
29.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
324 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 25, 2023
Anticipated Primary Completion Date :
Aug 25, 2027
Anticipated Study Completion Date :
Feb 25, 2030

Arms and Interventions

Arm Intervention/Treatment
Experimental: Orelabrutinib

Drug: Orelabrutinib
Orelabrutinib Tablets

Drug: Lenalidomide
Lenalidomide Capsules

Drug: Rituximab
Rituximab Injection
Placebo Comparator: Placebo

Drug: Lenalidomide
Lenalidomide Capsules

Drug: Rituximab
Rituximab Injection

Drug: Orelabrutinib Placebo
Orelabrutinib Placebo Tablets

Outcome Measures

Primary Outcome Measures

  1. IRC-assessed PFS [Through study completion, an average of 5 year.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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. Patients who are intolerant of CD20 monoclonal antibodies, or those who are resistant to lenalidomide and CD20 monoclonal antibodies.

  5. 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.

  6. Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510055
2 Henan Cancer Hospital Zhengzhou Henan China 450003
3 Henan Provincial Peoples Hospital Zhengzhou Henan China 450003
4 Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei China 430000
5 The First Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330006
6 Jiangxi Cancer Hospital Nanchang Jiangxi China 330029
7 The Second Hospital of Dalian Medical University Dalian Liaoning China 116023
8 The first Hospital of China Medical University Shenyang Liaoning China 110002
9 Yantai Yuhuangding Hospital Yantai Shandong China 264099
10 Yunnan Cancer Center Kunming Yunnan China 650118
11 The First Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310003

Sponsors and Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing InnoCare Pharma Tech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT06082102
Other Study ID Numbers:
  • ICP-CL-00123
First Posted:
Oct 13, 2023
Last Update Posted:
Oct 13, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Rituximab
Lenalidomide

Study Results

No Results Posted as of Oct 13, 2023