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

Launched by BEIJING INNOCARE PHARMA TECH CO., LTD. · Oct 8, 2023

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ClinConnect Summary

This clinical trial is studying a new treatment combination for patients with relapsed or refractory Marginal Zone Lymphoma, a type of blood cancer. The researchers want to see how well a drug called Orelabrutinib works when combined with Lenalidomide and Rituximab, compared to a placebo (a treatment that looks the same but has no active ingredients) along with Lenalidomide and Rituximab. The goal is to find out if this combination is more effective and safe than the standard treatment.

To participate in this trial, you need to be between 18 and 80 years old and have been diagnosed with Marginal Zone Lymphoma that has not responded to previous treatments. You should also have had one to three prior treatments for your condition. Participants will undergo regular check-ups and tests to monitor their health and the effectiveness of the treatment. It's important to know that you cannot have received certain other cancer treatments recently or be part of another clinical trial. This study is currently recruiting participants, so if you meet the criteria and are interested, you may want to discuss this option with your healthcare provider.

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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.