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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01007292
Collaborator
(none)
43
Enrollment
19
Locations
1
Arm
67
Duration (Months)
2.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
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 Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: YM155 plus rituximab

Drug: YM155
intravenous infusion

Biological: Rituximab
intravenous infusion
Other Names:
  • Rituxan
  • Mabthera

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. Confirmed Complete remission rate [After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment]

    2. Confirmed Partial remission rate [After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment]

    3. Time to response [After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment]

    4. Duration of response [After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment]

    5. Clinical benefit rate [After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment]

    6. Progression-free survival [After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment]

    7. Overall survival [1 year after the last subject completes treatment]

    8. Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) [After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site US2778 John B. Amos Cancer Center Columbus Georgia United States 31904
    2 Site US55 Loyola University Hospital - Maywood Maywood Illinois United States 60153
    3 Site US9 Mount Sinai School of Medicine New York New York United States 10029
    4 Site US2802 Mecklenburg Medical Group Charlotte North Carolina United States 28204
    5 Site US2149 Gabrail Cancer Center Research Canton Ohio United States 44718
    6 Site US402 University of Texas Health Science Center - San Antonio San Antonio Texas United States 78229
    7 Site FR1926 Institut Bergonie Bordeaux-cedex France 33076
    8 Site FR2700 Centre Antoine Lacassagne Nice France 06189
    9 Site FR476 Hopital Saint Louis Paris France 75475
    10 Site FR1889 Centre de Lutte Contre le Cancer - Centre Henri Becquerel Rouen France 76038
    11 Site FR1897 Hopital Bretonneau Tours France 37044
    12 Site ES1349 Hospital del Mar Barcelona Spain 08003
    13 Site ES1339 Hospital Universitario Ramon y Cajal Madrid Spain 28034
    14 Site ES2967 Hosptial Universitario Madrid Sanchinarro Madrid Spain 28050
    15 Site ES1346 Hospital Universitario de Salamanca Salamanca Spain 37007
    16 Site GB2702 Addenbrookes Hospital Cambridge United Kingdom CB2 0QQ
    17 Site GB1928 St. Georges Hospital London United Kingdom SW17 0QT
    18 Site GB2624 The Christie NHS Foundation Trust Manchester United Kingdom M20 4BX
    19 Site GB1903 Oxford Radcliffe Hospital Oxford United Kingdom OX3 7LJ

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Director: Senior Medical Director, Astellas Pharma Global Development

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT01007292
    Other Study ID Numbers:
    • 155-CL-031
    First Posted:
    Nov 4, 2009
    Last Update Posted:
    Oct 19, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by Astellas Pharma Inc
    Non-Hodgkin's Lymphoma
    relapsed
    CD20-Positive
    YM155
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Rituximab

    Study Results

    No Results Posted as of Oct 19, 2015