A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment
NCT ID: NCT01007292
Last Updated: 2015-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2009-11-30
2015-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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YM155 plus rituximab
YM155
intravenous infusion
Rituximab
intravenous infusion
Interventions
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YM155
intravenous infusion
Rituximab
intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Site US2778 John B. Amos Cancer Center
Columbus, Georgia, United States
Site US55 Loyola University Hospital - Maywood
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
Site FR1897 Hopital Bretonneau
Tours, , France
Site ES1349 Hospital del Mar
Barcelona, , Spain
Site ES1339 Hospital Universitario Ramon y Cajal
Madrid, , Spain
Site ES2967 Hosptial Universitario Madrid Sanchinarro
Madrid, , Spain
Site ES1346 Hospital Universitario de Salamanca
Salamanca, , Spain
Site GB2702 Addenbrookes Hospital
Cambridge, , United Kingdom
Site GB1928 St. Georges Hospital
London, , United Kingdom
Site GB2624 The Christie NHS Foundation Trust
Manchester, , United Kingdom
Site GB1903 Oxford Radcliffe Hospital
Oxford, , United Kingdom
Countries
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Other Identifiers
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155-CL-031
Identifier Type: -
Identifier Source: org_study_id
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