Back to resultsA Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment
Primary Purpose
Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YM155
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Non-Hodgkin's Lymphoma, relapsed, CD20-Positive, YM155
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 </= 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
Sites / Locations
- Site US2778 John B. Amos Cancer Center
- Site US55 Loyola University Hospital - Maywood
- Site US9 Mount Sinai School of Medicine
- Site US2802 Mecklenburg Medical Group
- Site US2149 Gabrail Cancer Center Research
- Site US402 University of Texas Health Science Center - San Antonio
- Site FR1926 Institut Bergonie
- Site FR2700 Centre Antoine Lacassagne
- Site FR476 Hopital Saint Louis
- Site FR1889 Centre de Lutte Contre le Cancer - Centre Henri Becquerel
- Site FR1897 Hopital Bretonneau
- Site ES1349 Hospital del Mar
- Site ES1339 Hospital Universitario Ramon y Cajal
- Site ES2967 Hosptial Universitario Madrid Sanchinarro
- Site ES1346 Hospital Universitario de Salamanca
- Site GB2702 Addenbrookes Hospital
- Site GB1928 St. Georges Hospital
- Site GB2624 The Christie NHS Foundation Trust
- Site GB1903 Oxford Radcliffe Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
YM155 plus rituximab
Arm Description
Outcomes
Primary Outcome Measures
Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission)
Secondary Outcome Measures
Confirmed Complete remission rate
Confirmed Partial remission rate
Time to response
Duration of response
Clinical benefit rate
Progression-free survival
Overall survival
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Full Information
NCT ID
NCT01007292
First Posted
September 24, 2009
Last Updated
September 29, 2015
Sponsor
Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT01007292
Brief Title
A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
Non-Hodgkin's Lymphoma, relapsed, CD20-Positive, YM155
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
YM155 plus rituximab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
YM155
Intervention Description
intravenous infusion
Intervention Type
Biological
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, Mabthera
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission)
Time Frame
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Secondary Outcome Measure Information:
Title
Confirmed Complete remission rate
Time Frame
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Title
Confirmed Partial remission rate
Time Frame
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Title
Time to response
Time Frame
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Title
Duration of response
Time Frame
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Title
Clinical benefit rate
Time Frame
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Title
Progression-free survival
Time Frame
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
Title
Overall survival
Time Frame
1 year after the last subject completes treatment
Title
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Time Frame
After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 </= 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senior Medical Director
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
Site US2778 John B. Amos Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Site US55 Loyola University Hospital - Maywood
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Site US9 Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Site US2802 Mecklenburg Medical Group
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Site US2149 Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Site US402 University of Texas Health Science Center - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site FR1926 Institut Bergonie
City
Bordeaux-cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Site FR2700 Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Site FR476 Hopital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Site FR1889 Centre de Lutte Contre le Cancer - Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Site FR1897 Hopital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Site ES1349 Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Site ES1339 Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Site ES2967 Hosptial Universitario Madrid Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Site ES1346 Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Site GB2702 Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Site GB1928 St. Georges Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Site GB2624 The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Site GB1903 Oxford Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment
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