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

Phase 2

Completed

• Conditions: Indolent B-Cell Non-Hodgkin's Lymphomas
• Interventions: Drug: Bendamustine hydrochloride injection

• Registration Number: NCT04569838
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2020-09
• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-09-25
• Last Update Submitted: 2020-09-25
• Study First Posted: 2020-09-30
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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.

  5. 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.

  6. Pregnant or breastfeeding women. 9. Has participated in other clinical trials within three months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bendamustine hydrochloride injection	Bendamustine hydrochloride injection	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (11)

Guangxi Medical University Affiliated Tumor Hospital; 🇨🇳 Nanning, Guangxi, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

First People's Hospital of Foshan; 🇨🇳 Foshan, Guangdong, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Guangzhou First People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

Southern Medical University Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China

Hubei Cancer Hospital; 🇨🇳 Wuhan, Hubei, China

The Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China