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The goal of this clinical trial is to learn if Zanubrutinib, Rituximab, and Lenalidomide works to treat marginal zone lymphoma as the first-line therapy. It will also learn about the safety of the treatment. The main questions it aims to answer are Does the combined therapy prolong patient survival? What medical problems do participants have when using this therapeutic approach? Researchers will observe the treatment to see if it works well than conventional therapies.
Participants will Administer drugs as required by the protocol Visit the clinic regularly for checkups and tests Keep a diary of their symptoms, examination and laboratory test indicators
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib, Rituximab, and Lenalidomide as first-line treatment for Marginal Zone Lymphoma | Drug | This study enrolls patients with marginal zone lymphoma who require the primary treatment. Participants receive a combined therapy consisting of zanubrutinib, rituximab, and lenalidomide. |
| Measure | Description | Time Frame |
|---|---|---|
| CRR | Complete remission rate | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate | 2 years |
| 2 year-progress free survival rate | the time from the start of treatment to the time when the patient has progressed on the disease or dies due to any cause in 2 years. |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma | Drug | This study enrolls patients with marginal zone lymphoma who require the primary treatment. Participants receive a combined therapy consisting of zanubrutinib, rituximab, and lenalidomide. |
|
| 2 years |
| TTR | Time from randomization to the first documentation of Complete Response (CR) or Partial Response (PR) , verified by computed tomography (CT) and positron emission tomography (PET)-CT at least 6 weeks apart | From randomization up to 24 months post-randomization |
| DoR | The interval from the date of first confirmed OR to the first evidence of progressive disease or death from any cause | From the date of first confirmed CR/PR up to 24 months post-confirmed response |
| OS | The time from the date of randomization to the date of death from any cause | From randomization up to 24 months post-randomization |
| Incidence rate of adverse events | 2 years |
| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
| D000069283 | Rituximab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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