Efficacy and Safety of Orelabrutinib Plus Lenalidomide and Rituximab (R2) Compared to Placebo Plus R2 in r/r Marginal Zone Lymphoma
- Conditions
- Relapsed/Refractory Marginal Zone Lymphoma
- Registration Number
- NCT06082102
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 324
Inclusion Criteria:<br><br> 1. Age = 18 years and = 80 years, either sex.<br><br> 2. Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or<br> extra-nodal).<br><br> 3. At least one and no more than 3 prior lines of systemic therapy (CD20 targeted<br> therapy included in at least one line).<br><br> 4. Relapsed or refractory disease.<br><br> 5. At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or<br> enhanced magnetic resonance imaging (MRI).<br><br> 6. ECOG performance status (PS) score of 0-2.<br><br>Exclusion Criteria:<br><br> 1. Administration of the specified anti-tumor therapies within 2 weeks prior to the<br> first dose of the study treatment.<br><br> 2. Administration of any other investigational product within 4 weeks prior to the<br> first dose of the study treatment, or concurrent participation in another clinical<br> trial.<br><br> 3. Prior treatment with any types of BTK inhibitor.<br><br> 4. Prior allogeneic hematopoietic stem cell transplantation (Allo-HSCT), or Autologous<br> hematopoietic stem cell transplantation (ASCT) within 6 months prior to the first<br> dose of the study treatment; or prior CAR-T cell therapy.<br><br> 5. Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal<br> involvements.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method IRC-assessed PFS
- Secondary Outcome Measures
Name Time Method