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This is a prospective, multiple-centers, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in high-risk treatment-naive patients with follicular lymphomas
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) | Drug | Induction therapy: The ZGR regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 28 days. Participants will receive a total of 6 cycles. Dosage:
Maintenance therapy:
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria | At the end of Cycle 6 (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CR) | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria. | At the end of Cycle 6 (each cycle is 28 days) |
| Partial response rate (PR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao, M.D. and Ph.D | Contact | +862164370045 | 610707 | zwl_trial@163.com |
| Pengpeng Xu, M.D. and Ph.D | Contact | +862164370045 | 610707 | pengpeng_xu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | China |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
| C543332 | obinutuzumab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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|
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
| At the end of Cycle 6 (each cycle is 28 days) |
| Duration of response | Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT. | Baseline up to data cut-off (up to approximately 2 years) |
| 2-year progression free survival rate | progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first. | Baseline up to data cut-off (up to approximately 2 years) |
| 2-year overall survival rate | progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of death from any cause. | Baseline up to data cut-off (up to approximately 2 years) |
| 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 |