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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01007292
First received: September 24, 2009
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Non-Hodgkin's Lymphoma
Drug: YM155
Biological: Rituximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Confirmed Complete remission rate [ Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment ] [ Designated as safety issue: No ]
  • Confirmed Partial remission rate [ Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment ] [ Designated as safety issue: No ]
  • Clinical benefit rate [ Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year after the last subject completes treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: November 2009
Estimated Study Completion Date: September 2016
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YM155 plus rituximab Drug: YM155
intravenous infusion
Biological: Rituximab
intravenous infusion
Other Names:
  • Rituxan
  • Mabthera

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007292

Locations
United States, Georgia
John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
United States, Illinois
Loyola University Hospital
Maywood, Illinois, United States, 60153
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
United States, North Carolina
Blumenthal Cancer Center Oncology Research
Charlotte, North Carolina, United States, 28204
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Texas
CTRC at The University of Texas Health Science Center
San Antonio, Texas, United States, 78229
France
Institut Bergonie
Bordeaux-cedex, France, 33076
Centre Antoine Lacassagne
Nice, France, 06189
Hopital Saint Louis
Paris, France, 75475
Centre Henri Becquerel
Rouen, France, 76038
Hopital Bretonneau
Tours, France, 37044
Spain
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Universitario Madrid Sanchinarro
Madrid, Spain, 28050
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
St George's Healthcare NHS Trust
London, United Kingdom, SW17 0QT
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
ORH Level 2 Cancer and Haematology Centre
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Senior Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01007292     History of Changes
Other Study ID Numbers: 155-CL-031
Study First Received: September 24, 2009
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines

Keywords provided by Astellas Pharma Inc:
Non-Hodgkin's Lymphoma
relapsed
CD20-Positive
YM155

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 26, 2014