Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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
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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

43

Study ID:

NCT01007292

Recruitment Status:

Completed

Sponsor:

Astellas Pharma Inc

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There are 19 Locations for this study

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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-cedex , 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 0, United Kingdom
Site GB1928 St. Georges Hospital
London , SW17 , United Kingdom
Site GB2624 The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom
Site GB1903 Oxford Radcliffe Hospital
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

43

Study ID:

NCT01007292

Recruitment Status:

Completed

Sponsor:


Astellas Pharma Inc

How clear is this clinincal trial information?

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