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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Site US2778 John B. Amos Cancer Center
Columbus, Georgia, United States
Site US55 Loyola University Hospital - Maywood
Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission)
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Confirmed Complete remission rate
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Confirmed Partial remission rate
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Time to response
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Duration of response
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Clinical benefit rate
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Progression-free survival
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Overall survival
Time frame: 1 year after the last subject completes treatment
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Time frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
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Maywood, Illinois, United States
Site US9 Mount Sinai School of Medicine
New York, New York, United States
Site US2802 Mecklenburg Medical Group
Charlotte, North Carolina, United States
Site US2149 Gabrail Cancer Center Research
Canton, Ohio, United States
Site US402 University of Texas Health Science Center - San Antonio
San Antonio, Texas, United States
Site FR1926 Institut Bergonie
Bordeaux, France
Site FR2700 Centre Antoine Lacassagne
Nice, France
Site FR476 Hopital Saint Louis
Paris, France
Site FR1889 Centre de Lutte Contre le Cancer - Centre Henri Becquerel
Rouen, France
...and 9 more locations