Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this phase 2 trial is to test the safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with DLBCL.
The investigators will evaluate safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with diffuse large B-cell lymphoma post complete remission and have completed planed courses of chemotherapy . Event-free survival (EFS), progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maintenance Therapy | Experimental | Patients were treated by Zanubrutinib plus Lenalidomide as Maintenance Therapy |
|
| No maintenance Therapy | No Intervention | Patients received no maintenance Therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib plus Lenalidomide as Maintenance Therapy | Drug | Patients were treated by Zanubrutinib(160mg po bid d1-28) plus Lenalidomide(25mg po qd d1-14) as maintenance therapy until 2 years post chemotherpay |
| Measure | Description | Time Frame |
|---|---|---|
| EFS | EFS was defined as the time from treatment initiation to progression, relapse, new treatment, or death by any cause, whichever occurred first. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS was defined as the time from study entry until disease progression or death by any cause | 2 years |
| OS | OS was defined as the time from treatment initiation to death by any cause. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liren Qian, PhD | Contact | +861066947192 | qlr2007@126.com |
| Name | Affiliation | Role |
|---|---|---|
| qlr2007@126.com Qian, PhD | Navy General Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navy General Hospital | Recruiting | Beijing | Beijing Municipality | 100048 | China |
Not provided
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
| D000077269 | Lenalidomide |
| D008283 | Maintenance |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 2 years |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| 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 |
| D005159 | Health Care Facilities Workforce and Services |