A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment
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
1 other identifier
interventional
43
4 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2009
Longer than P75 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedFirst Posted
Study publicly available on registry
November 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedOctober 19, 2015
September 1, 2015
3.3 years
September 24, 2009
September 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Confirmed Complete remission rate
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
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
Clinical benefit rate
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
- +3 more secondary outcomes
Study Arms (1)
YM155 plus rituximab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Site US2778 John B. Amos Cancer Center
Columbus, Georgia, 31904, United States
Site US55 Loyola University Hospital - Maywood
Maywood, Illinois, 60153, United States
Site US9 Mount Sinai School of Medicine
New York, New York, 10029, United States
Site US2802 Mecklenburg Medical Group
Charlotte, North Carolina, 28204, United States
Site US2149 Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
Site US402 University of Texas Health Science Center - San Antonio
San Antonio, Texas, 78229, United States
Site FR1926 Institut Bergonie
Bordeaux, 33076, France
Site FR2700 Centre Antoine Lacassagne
Nice, 06189, France
Site FR476 Hopital Saint Louis
Paris, 75475, France
Site FR1889 Centre de Lutte Contre le Cancer - Centre Henri Becquerel
Rouen, 76038, France
Site FR1897 Hopital Bretonneau
Tours, 37044, France
Site ES1349 Hospital del Mar
Barcelona, 08003, Spain
Site ES1339 Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Site ES2967 Hosptial Universitario Madrid Sanchinarro
Madrid, 28050, Spain
Site ES1346 Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Site GB2702 Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Site GB1928 St. Georges Hospital
London, SW17 0QT, United Kingdom
Site GB2624 The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Site GB1903 Oxford Radcliffe Hospital
Oxford, OX3 7LJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Senior Medical Director
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2009
First Posted
November 4, 2009
Study Start
November 1, 2009
Primary Completion
March 1, 2013
Study Completion
June 1, 2015
Last Updated
October 19, 2015
Record last verified: 2015-09