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

Completed · Phase 2

Conditions studied: Non-Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID

NCT01007292

Run by

Astellas Pharma Inc

People needed

43

Starts

2009-11-01

Expected to finish

2015-06-01

Last updated by the study team

2015-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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