Combining Orelabrutinib with Lenalidomide and Rituximab for treating relapsed Marginal Zone Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of a combination treatment involving Orelabrutinib, Lenalidomide, and Rituximab compared to a placebo with the same regimen in patients with relapsed or refractory Marginal Zone Lymphoma. The study aims to determine whether the addition of Orelabrutinib can improve treatment outcomes for patients who have not responded to previous therapies. Participants will be monitored for measurable lesions using advanced imaging techniques to assess the effectiveness of the treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Bengbu Medical College
  Bengbu, Auhui, China Recruiting
• Beijing Tiantan Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Beijing Tongren Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Guangdong Provincial Hospital of Chinese Medicine
  Guangzhou, Guangdong, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Alexia Lu
• Email: CO_HGRAC@innocarepharma.com
• Phone: 010-66609745

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Orelabrutinib plus zebetuzumab and lenalidomide vs bendamustine‑rituximab for newly diagnosed marginal zone lymphoma

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• Orelabrutinib with rituximab and optional autologous stem cell transplant for mantle cell lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.