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
This study aims to assess the clinical efficacy and safety of obinutuzumab in Chinese patients with indolent non-Hodgkin B-cell Lymphoma (predominantly Follicular lymphoma and Marginal zone lymphoma) in a real-world setting.
This study was a prospective, multicenter, non-interventional, real-world study. The study will be divided into two cohorts: Cohort 1 is the younger cohort (aged ≥ 18 and < 60 years at the start of treatment); Cohort 2 is the older cohort (aged ≥ 60 years at the start of treatment). Patients in this study will receive obinutuzumab-contained regimens according to the investigators' clinical opinion.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | the younger cohort (aged ≥ 18 and < 60 years at the start of treatment) |
| |
| Cohort 2 | the older cohort (aged ≥ 60 years at the start of treatment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Endpoints | The best objective response rate (ORR), and CR rate; ORR and CR rate at the end of treatment; DCR, DoR, TTNT, PFS, DFS, and OS. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints | All AEs, SAEs, Grade 3 AEs, and all other safety variables, including vital signs, Physical examination results, and laboratory parameters. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoints | Subgroup analyses will be performed for some special populations, such as in high-risk patients | 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
patients with FL and MZL who started treatment with otuzumab between June 2021 and April 2023.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenyu Shi, PhD | Contact | +86 13515203737 | shiwenyu@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changzhou No.2 People's Hospital | Changzhou | Jiangsu | China |
all IPD that underlie results in a publication
starting 6 months after publication
IPD could be shared by contacting the corresponding author via email after publication.
Not provided
Not provided
Not provided
Not provided
Not provided
| The First People's hospital of Changzhou | Changzhou | Jiangsu | China |
|
| Huai'an First People's hospital | Huai'an | Jiangsu | China |
|
| Jiangyin People's Hospital | Jiangyin | Jiangsu | China |
|
| Jingjiang People's Hospital | Jingjiang | Jiangsu | China |
|
| The first people's hospital of Lianyungang | Lianyungang | Jiangsu | China |
|
| The second people's hospital of Lianyungang | Lianyungang | Jiangsu | China |
|
| Jiangsu Province Hospital of Chinese Medicine | Nanjing | Jiangsu | China |
|
| Jiangsu Province Hospital | Nanjing | Jiangsu | China |
|
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | China |
| Nanjing Jiangning Hospital | Nanjing | Jiangsu | China |
|
| Nantong Tumor Hospital | Nantong | Jiangsu | China |
|
| Affiliated Hospital of Nantong University | Nanyang | Jiangsu | China |
|
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
|
| Jiangsu Taizhou People's Hospital | Taizhou | Jiangsu | China |
|
| Affiliated Hospital of Jiangnan University | Wuxi | Jiangsu | China |
|
| Wuxi People's Hospital | Wuxi | Jiangsu | China |
|
| Wuxi Second People's Hospital | Wuxi | Jiangsu | China |
|
| Yancheng No.1 People's Hospital | Yancheng | Jiangsu | China |
|
| Yancheng Third People's Hospital | Yancheng | Jiangsu | China |
|
| Subei People's Hospital | Yangzhou | Jiangsu | China |
|
| Yixing People's Hospital | Yixing | Jiangsu | China |
|
| Zhangjiagang First People's Hospital | Zhangjiagang | Jiangsu | China |
|
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
|
| Zhenjiang First People's Hospital | Zhenjiang | Jiangsu | China |
|
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C543332 | obinutuzumab |
Not provided
Not provided
Not provided