Non-Hodgkin's Lymphoma Clinical Trial
Official title:
A Phase II, Multicenter, Open-Label Study Of YM155 Plus Rituximab In Previously Treated Subjects With CD20-Positive B Cell Non-Hodgkin's Lymphoma Who Are Ineligible For Or Have Previously Received An Autologous Stem Cell Transplant
The purpose of this study is to evaluate response rate, survival, safety and tolerability of YM155 given in combination with rituximab in subjects with Non-Hodgkin's Lymphoma.
This is an outpatient study. All subjects enrolled in this study will receive YM155 and
rituximab given during 14 day cycles. Each subject will be assessed at the end of each cycle
to determine if he or she may continue to the next cycle. Each subject will be eligible to
continue receiving the combination regimen in this study until one of the discontinuation
criteria is met.
If a subject discontinues treatment without progressive disease (PD) that subject will
complete follow-up visits every 12 weeks for 1 year or until initiating another systemic
anti-lymphoma treatment, exhibiting PD, or death.
Each subject will be contacted by the study site every 12 weeks for survival following the
End of Treatment Visit. The contacts will continue until death or for no more than 1 year.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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