The purpose of this study is to determine whether bendamustine HCl for injection is safe and effective in the treatment of Rituximab refractory or relapsed B-cell indolent lymphoma.
This is multicenter, open label study to evaluate the safety and efficacy of bendamustine HCl in patients with indolent Non-hodgkin's lymphoma and relapsed after rituximab treatment. This injection will be given through i.v. infusion in \>= 60 minutes on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for up to 8 cycles unless progressive disease or unacceptable toxicity take place. Patients will be followed for up to 1 year before evaluating progression free survival (PFS) and overall survival (OS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
for injection
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGTianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGOverall response rate (ORR=CR+PR) of bendamustine hydrochloride in patients who are refractory to rituximab therapy.
Time frame: 18 months
Safety profile of Bendamustine hydrochloride in this patient population
Time frame: 18 months
Progression free survival (PFS)
Time frame: 18 months
Overall survival (OS)
Time frame: 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.