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This is a multicenter, phase 2, randomized trial to compare rituximab maintenance with observation after rituximab and lenalidomide (R2) induction therapy in patients with previously untreated marginal zone lymphoma. Patients who achieve complete response or partial response after R2 induction will be randomized to receive rituximab maintenance or observation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Experimental | Patients will receive induction therapy with rituximab and lenalidomide. If CR or PR: maintenance therapy with rituximab every 8 weeks for 2 years. |
|
| Observation | Active Comparator | Patients will receive induction therapy with rituximab and lenalidomide. If CR or PR: observation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Patients will receive R2 induction therapy consisting of rituximab and lenalidomide. Patients who achieve complete response or partial response after induction will receive rituximab maintenance every 8 weeks for up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year progression-free survival rate | The 2-year progression-free survival rate is defined as the proportion of patients who are alive without disease progression at 2 years after randomization. | At 2 years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | Complete response rate is defined as the proportion of patients who achieve complete response according to the Lugano 2014 criteria during the maintenance or observation period. | Up to 24 months after randomization |
| Overall response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cai Qingqing | Contact | (020)87342823 | caiqq@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun yat-sen university cancer center | Guangzhou | Guangdong | 510060 | China |
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| 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 |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D019370 | Observation |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Observation | Other | Patients will receive R2 induction therapy consisting of rituximab and lenalidomide. Patients who achieve complete response or partial response after induction will undergo observation without maintenance anti-lymphoma therapy. |
|
Overall response rate is defined as the proportion of patients who achieve complete response or partial response according to the Lugano 2014 criteria during the maintenance or observation period. |
| Up to 24 months after randomization |
| Duration of response | Duration of response is defined as the time from the first documented complete response or partial response to disease progression, relapse, or death from any cause, whichever occurs first. | Up to 24 months after randomization |
| Overall survival | Overall survival is defined as the time from randomization to death from any cause. | Up to 24 months after randomization |
| Event-free survival | Event-free survival is defined as the time from randomization to disease progression, relapse, initiation of new systemic anti-lymphoma therapy, or death from any cause, whichever occurs first. | Up to 24 months after randomization |
| Disease-free survival | Disease-free survival is defined as the time from the first documented complete response to disease relapse, progression, or death from any cause, whichever occurs first. | Up to 24 months after randomization |
| Incidence of progression of disease within 24 months | POD24 is defined as the proportion of patients who experience disease progression, relapse, or death from any cause within 24 months from the start of frontline induction therapy. | Within 24 months from the start of induction therapy |
| Patient-reported outcomes | Patient-reported outcomes will be assessed using the EORTC QLQ-C30 questionnaire. | Up to 24 months after randomization |
| Incidence of adverse events and serious adverse events | The incidence and severity of adverse events and serious adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. | Up to 30 days after the last study treatment or during follow-up as clinically indicated |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008722 | Methods |
| D008919 | Investigative Techniques |