A Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Indolent B-Cell Non-Hodgkin's Lymphomas

Intervention / Treatment
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* Drug: Bendamustine hydrochloride injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bendamustine hydrochloride injection<br>Bendamustine hydrochloride injection 120 mg/m² or 100 mg/m² intravenously (IV) on Day 1 and Day 2 of 21-day cycle (6-8 cycles maximum) for non-hodgkin's lymphomas or chronic lymphocytic leukemia. After 6-8 cycles, the course of treatment could be added based on patient's benefit and investigator's determination. | Drug: Bendamustine hydrochloride injection<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate（ORR） | Percentage of participants achieving complete response (CR) and partial response (PR). | Baseline up to 30 weeks | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |