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

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.91 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Indolent B-Cell Non-Hodgkin's Lymphomas

Interventions

Bendamustine hydrochloride injectionDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (11)

Fujian Cancer Hospital

Fuzhou, Fujian, China

First People's Hospital of Foshan

Foshan, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Objective Response Rate（ORR）

Percentage of participants achieving complete response (CR) and partial response (PR).

Time frame: 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.

Time frame: Baseline up to 30 weeks

Secondary Outcomes

Progression Free Survival (PFS)

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

Time frame: 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.

Time frame: Baseline up to 30 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.