Indolent B-Cell Non-Hodgkin's Lymphomas
Conditions
Brief summary
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.
Interventions
Bendamustine is a bifunctional alkylating agent. It cross-links DNA single strand and double strand by alkylation,then destroys the function and synthesis of DNA, and makes the DNA and protein, protein and protein cross-linking, has potential to treat various tumors
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate（ORR） | Baseline up to 30 weeks | Percentage of participants achieving complete response (CR) and partial response (PR). |
| Duration of Response (DOR) | Baseline up to 30 weeks | DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Baseline up to 30 weeks | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause. |
| Overall Survival (OS) | Baseline up to 30 weeks | 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. |
Countries
China
Outcome results
None listed