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
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission)
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
No
Senior Medical Director
Study Director
Astellas Pharma Global Development
United States: Food and Drug Administration
155-CL-031
NCT01007292
November 2009
December 2013
Name | Location |
---|---|
Yale Cancer Center | New Haven, Connecticut 06520-8028 |
John B. Amos Cancer Center | Columbus, Georgia 31904 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Mount Sinai Hospital | New York, New York 10029 |
Loyola University Hospital | Maywood, Illinois 60153 |
Blumenthal Cancer Center Oncology Research | Charlotte, North Carolina 28204 |
CTRC at The University of Texas Health Science Center | San Antonio, Texas 78229 |