Indolent B-Cell Non-Hodgkin's Lymphomas Clinical Trial
Official title:
A Multicenter, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection in Subjects With Rituximab-resistant Indolent B-Cell Non-Hodgkin's Lymphomas
| Verified date | September 2020 |
| Source | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a study to evaluate the efficacy and safety of Bendamustine Hydrochloride Injection in subjects with Rituximab-resistant Indolent B-Cell Non-Hodgkin's Lymphomas.
| Status | Completed |
| Enrollment | 91 |
| Est. completion date | August 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - 1. Inert lymphoma, including follicular lymphoma (FL), extranodal marginal zone B-cell lymphomas of the mucosa-associated lymphoid tissue (MALT), lymphoplasmacytic lymphoma, mantle cell lymphoma, small lymphocyte B-cell lymphoma and chronic lymphoblastic leukemia (CLL). 2. At least one measurable lesion with the longest diameter > 1.5 cm and the short diameter > 1.0 cm, or the peripheral blood B lymphocyte = 5.0×109/L. 3.Adequate laboratory indicators. 4. Has received one to three chemotherapy regimens (with or without rituximab) before enrollment. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy = 3 months. 6. Understood and signed an informed consent form. Exclusion Criteria: - 1. Patients who could not tolerate bendamustine treatment according to the investigators' judgment. 2. Has received anti-tumor treatment (including major surgery) in the last 4 weeks. 3. Transformed into high malignant lymphoma (secondary to low-grade follicular lymphoma); grade 3B follicular lymphoma. 4. Has received corticosteroids regularly in the last 4 weeks. 5. Has a history of central nervous system disease or central nervous system disease. 6. Has other tumors. 7. Has suffered from serious infection and other drugs or mental illness,which affects signing informed consent form and follow-up visit. 8. Pregnant or breastfeeding women. 9. Has participated in other clinical trials within three months. |
| Country | Name | City | State |
|---|---|---|---|
| China | First People's Hospital of Foshan | Foshan | Guangdong |
| China | Fujian Cancer Hospital | Fuzhou | Fujian |
| China | Guangzhou First People's Hospital | Guangzhou | Guangdong |
| China | Southern Medical University Nanfang Hospital | Guangzhou | Guangdong |
| China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
| China | Guangxi Medical University Affiliated Tumor Hospital | Nanning | Guangxi |
| China | Affiliated Hospital of Nantong University | Nantong | Jiangsu |
| China | Shenzhen People's Hospital | Shenzhen | Guangdong |
| China | The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu |
| China | Hubei Cancer Hospital | Wuhan | Hubei |
| China | Henan Cancer Hospital | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective Response Rate(ORR) | Percentage of participants achieving complete response (CR) and partial response (PR). | Baseline up to 30 weeks | |
| Primary | Duration of Response (DOR) | DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment. | Baseline up to 30 weeks | |
| Secondary | Progression Free Survival (PFS) | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause. | Baseline up to 30 weeks | |
| Secondary | Overall Survival (OS) | OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. | Baseline up to 30 weeks |