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

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04569838
• Collaborator: (none)
• Enrollment: 91
• Locations: 11
• Arm: 1
• Actual Duration (Months): 51
• Patients Per Site: 8.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Indolent B-Cell Non-Hodgkin's Lymphomas	Drug: Bendamustine hydrochloride injection	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 91 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 1, 2012
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Bendamustine hydrochloride injection; 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

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate（ORR） [Baseline up to 30 weeks]

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

2. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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).

1. 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.

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.

2. Understood and signed an informed consent form.

Exclusion Criteria:

• 1. Patients who could not tolerate bendamustine treatment according to the investigators' judgment.

1. Has received anti-tumor treatment (including major surgery) in the last 4 weeks.

2. Transformed into high malignant lymphoma (secondary to low-grade follicular lymphoma); grade 3B follicular lymphoma.

3. Has received corticosteroids regularly in the last 4 weeks. 5. Has a history of central nervous system disease or central nervous system disease.

4. 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.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fujian Cancer Hospital	Fuzhou	Fujian	China	350014
2	First People's Hospital of Foshan	Foshan	Guangdong	China	528000
3	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510060
4	Guangzhou First People's Hospital	Guangzhou	Guangdong	China	510180
5	Southern Medical University Nanfang Hospital	Guangzhou	Guangdong	China	510515
6	Shenzhen People's Hospital	Shenzhen	Guangdong	China	518020
7	Guangxi Medical University Affiliated Tumor Hospital	Nanning	Guangxi	China	530021
8	Henan Cancer Hospital	Zhengzhou	Henan	China	450008
9	Hubei Cancer Hospital	Wuhan	Hubei	China	430079
10	Affiliated Hospital of Nantong University	Nantong	Jiangsu	China	215006
11	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215006

Sponsors and Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04569838
• Other Study ID Numbers: BDMS-C10IICS-PRT
• First Posted: Sep 30, 2020
• Last Update Posted: Sep 30, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Bendamustine Hydrochloride

Study Results

No Results Posted as of Sep 30, 2020