Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT06082102
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06082102
Study Brief:
Protocol Section:
NCT06082102