Bendamustine in the Treatment of Chinese Patients With Indolent Non-Hodgkin Lymphoma Refractory to Rituximab Treatment
The primary objective of the study is to determine the overall response rate (ORR), which includes complete response (CR) and partial response (PR), to bendamustine treatment in patients with indolent non-Hodgkin lymphoma (NHL) that has progressed after rituximab or a rituximab-containing therapy.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Study to Evaluate Bendamustine Hydrochloride in the Treatment of Chinese Patients With Indolent Non-Hodgkin Lymphoma (NHL) Refractory to Rituximab Treatment|
- Overall response rate (ORR) [ Time Frame: up to 2.5 Years ] [ Designated as safety issue: No ]The ORR is defined as the proportion of patients who achieve a best response of complete response (CR) or partial response (PR) during the study based on the modified International Workshop Response Criteria.
- Duration of response (DOR) for patients who achieved a best response of PR or better [ Time Frame: up to 2.5 Years ] [ Designated as safety issue: No ]Duration of response (DOR) is defined as the time from the date of 1st documentation of response to the 1st documentation of disease progression, new anticancer therapy, or death (regardless of cause), whichever occurs first, for patients with a best response of CR or PR determined by the modified International Workshop Response Criteria.
- Progression-free Survival for all patients [ Time Frame: up to 2.5 Years ] [ Designated as safety issue: No ]Progression free survival (PFS) is defined as the time from the date of the 1st administration of bendamustine to the 1st documentation of disease progression/relapse, new anticancer therapy, or death (regardless of cause), whichever occurred first for all patients.
- Pharmacokinetic Parameters [ Time Frame: Prior to the start of infusion on Day 1 for up to 24 hours during Cycle 1 ] [ Designated as safety issue: No ]
Blood samples will be collected from a subset of 15 patients during Cycle 1 at a minimum of 3 study centers to evaluate the following:
- maximum observed plasma drug concentration (Cmax)
- time to maximum observed drug concentration (tmax) by inspection
- area under the plasma drug concentration by time curve from time 0 to the time of the last measurable drug concentration (AUC0-t)
- AUC from time zero to infinity (AUC0-∞)
- percentage extrapolation
- apparent plasma terminal elimination rate constant (λz) and associated half-life (t½)
- Safety Parameters [ Time Frame: From signing of the informed consent form through 30 days after the last administration ] [ Designated as safety issue: Yes ]
Safety will be assessed by the following:
- occurrence of adverse events throughout the study
- clinical laboratory (serum chemistry and hematology) test results
- vital signs (blood pressure, pulse, and body temperature) measurements
- World Health Organization (WHO) performance status
- electrocardiogram (ECG) findings
- concomitant medication usage
- the need for hematologic supportive care
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Bendamustine hydrochloride
This is a single-arm study, in which all subjects enrolled are administered the study drug.
Drug: Bendamustine hydrochloride
Bendamustine will be supplied in 20-mL, amber, single-use vials containing 100 mg of bendamustine hydrochloride as a white to off-white lyophilized powder. The drug will be labeled as study drug with the study number and batch number. Patients will be administered bendamustine hydrochloride as a 60-minute infusion, and not more than 120 minutes, on days 1 and 2 of each 21-day treatment cycle for 6 planned cycles or up to 8 total cycles. Dose reductions or modifications may be made as appropriate. Day 1 only of the 21-day cycle may be ±1 day. Day 2 dosing should begin 24 ±4 hours after the start of the day 1 dose.
Other Name: Treanda®
This is a multicenter, nonrandomized, open-label, single-agent clinical study conducted in China, and is designed to investigate the use of bendamustine in the treatment of Chinese patients with relapsed, rituximab-refractory indolent NHL. The study consists of a screening period of up to 4 weeks, a treatment period of approximately 24 weeks (up to eight 21-day cycles), and a long-term follow-up period for up to 2 years after the last dose of study drug. Patients are expected to participate in this study for approximately 2.5 years.
|Contact: US Teva Medical Information||800-896-5855|
|Teva Investigational Site 004||Not yet recruiting|
|Teva Investigational Site 002||Not yet recruiting|
|Teva Investigational Site 003||Recruiting|
|Teva Investigational Site 001||Recruiting|
|Teva Investigational Site 015||Recruiting|
|Teva Investigational Site 010||Not yet recruiting|
|Teva Investigational Site 007||Not yet recruiting|
|Teva Investigational Site 008||Not yet recruiting|
|Guangzhou, Guangdong Province, China|
|Teva Investigational Site 011||Not yet recruiting|
|Hangzhou, , Zhejiang, China|
|Teva Investigational Site 013||Recruiting|
|Nanjing, Jiangsu Province, China|
|Teva Investigational Site 012||Not yet recruiting|
|Nanjing,Jiangsu Province, China|
|Teva Investigational Site 005||Not yet recruiting|
|Teva Investigational Site 006||Recruiting|
|Teva Investigational Site 009||Not yet recruiting|
|Shenyang City, Liaoning Province, China|
|Teva Investigational Site 014||Not yet recruiting|