Clinical trial NCT04569838: A Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Indolent B-Cell Non-Hodgkin's Lymphomas
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-30
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate（ORR）
timeFrame: Baseline up to 30 weeks
measure: Duration of Response (DOR)
timeFrame: Baseline up to 30 weeks
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline up to 30 weeks
measure: Overall Survival (OS)
timeFrame: Baseline up to 30 weeks
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Foshan
country: China
facility: First People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
state: Guangxi
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References: