A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment

Phase 2

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Any stage, histologically confirmed CD20-positive primary or transformed diffuse large B cell lymphoma (DLBCL)or grade 3 follicular lymphoma (FL)
Ineligible for or have previously received an autologous stem cell transplant (ASCT)
Relapsed following receipt of the last dose of systemic chemotherapy or ASCT
At least one prior chemotherapy regimen. Prior chemotherapy regimen must have contained anthracycline (unless contraindicated)
If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period
Eastern Cooperative Oncology Group (ECOG) performance status </= 1

Exclusion Criteria

Use of any standard/experimental anti-lymphoma drug therapy within 21 days of the Baseline Visit
Use of systemic steroids within 5 days of the Baseline Visit (except for the purposes of pre-medication prior to study regimen treatment)
Prior allogeneic stem cell transplant (SCT)
The subject has been previously treated with YM155
The subject has known human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibody
The subject has received other investigational therapy or procedures within 21 days prior to the first study drug administration

Arm && Interventions

Group	Intervention	Description
YM155 plus rituximab	YM155	-
YM155 plus rituximab	Rituximab	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission)	After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment

Secondary Outcome Measures

Name	Time	Method
Confirmed Complete remission rate	After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Time to response	After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Duration of response	After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Confirmed Partial remission rate	After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Clinical benefit rate	After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Progression-free survival	After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Overall survival	1 year after the last subject completes treatment
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)	After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment

Locations (19): Site FR1926 Institut Bergonie
🇫🇷
Bordeaux-cedex, France
Site FR2700 Centre Antoine Lacassagne
🇫🇷
Nice, France
Site FR1897 Hopital Bretonneau
🇫🇷
Tours, France
Site FR1889 Centre de Lutte Contre le Cancer - Centre Henri Becquerel
🇫🇷
Rouen, France
Site US2802 Mecklenburg Medical Group
🇺🇸
Charlotte, North Carolina, United States
Site GB2624 The Christie NHS Foundation Trust
🇬🇧
Manchester, United Kingdom
Site GB1928 St. Georges Hospital
🇬🇧
London, United Kingdom
Site GB2702 Addenbrookes Hospital
🇬🇧
Cambridge, United Kingdom
Site ES1346 Hospital Universitario de Salamanca
🇪🇸
Salamanca, Spain
Site FR476 Hopital Saint Louis
🇫🇷
Paris, France
Site ES1349 Hospital del Mar
🇪🇸
Barcelona, Spain
Site ES1339 Hospital Universitario Ramon y Cajal
🇪🇸
Madrid, Spain
Site US2778 John B. Amos Cancer Center
🇺🇸
Columbus, Georgia, United States
Site US9 Mount Sinai School of Medicine
🇺🇸
New York, New York, United States
Site ES2967 Hosptial Universitario Madrid Sanchinarro
🇪🇸
Madrid, Spain
Site GB1903 Oxford Radcliffe Hospital
🇬🇧
Oxford, United Kingdom
Site US55 Loyola University Hospital - Maywood
🇺🇸
Maywood, Illinois, 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