Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects

This study has been terminated.
(Futility boundary at interim analysis not met)
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00498914
First received: July 10, 2007
Last updated: May 8, 2009
Last verified: May 2009
  Purpose

A study in subjects with a type of B cell lymphoma (DLBCL)to evaluate the response rate, efficacy, safety and tolerability of YM155


Condition Intervention Phase
Lymphoma, Large-Cell, Diffuse
Lymphoma, B-Cell Refractory
Drug: YM155
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 15 treatment cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety, efficacy, pharmacokinetics, and tolerability [ Time Frame: 15 treatment cycles ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: June 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: YM155
Continuous IV infusion

Detailed Description:

1 arm (Active), Phase 2 Study to evaluate response rate, efficacy, safety and tolerability of YM155

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects aged 18 years or older
  • Histologically confirmed primary DLBCL of any stage
  • Refractory to the last treatment regimen
  • Previously treated with the following treatment regimens:
  • Anthracycline-based combination chemotherapy with rituximab
  • Second-line combination chemotherapy
  • Autologous BMT if the subject was eligible and did not refuse the procedure
  • At least one measurable lesion defined as > 1.5 cm in the longest diameter
  • No known central nervous system involvement
  • ECOG performance status < 2
  • Life expectancy > 12 weeks
  • If female, non-pregnant and non-lactating
  • IRB-approved consent and HIPAA Authorization

Exclusion Criteria:

  • Transformed, composite or discordant lymphoma
  • Therapy for lymphoma within 21 days prior to the first dose of YM155
  • Within 4 weeks of the screening FDG-PET scan, receipt of the following:
  • Radiation therapy
  • Surgical procedures (except biopsies and central catheter / port placement)
  • Active infection (bloodstream or deep tissue)
  • Inadequate marrow, hepatic and/or renal function
  • Serum creatinine > 1.5 x ULN or calculated serum creatinine clearance < 60 mL/min
  • Absolute Neutrophil Count (ANC) < 750/mm3
  • Platelet < 50,000/mm3
  • Alanine Transaminase (ALT) and Aspartate Transaminase (AST) > 2.5 x ULN; > 5 x ULN if secondary to liver metastases
  • Treated with > 3 prior treatment regimens. The following should be considered:
  • Planned maintenance therapy should be considered as part of the previous treatment regimen
  • Any preparative treatment (salvage chemotherapy, high-dose chemotherapy, radiation therapy, etc.) should be included with the autologous BMT or PBSCT as one treatment
  • Prior allogeneic BMT or PBSCT
  • Previously treated with YM155
  • Other investigational therapy or procedures within 28 days
  • Known HIV, hepatitis B surface antigen, or hepatitis C antibody
  • Other malignancy requiring treatment within 2 years
  • Significant and/or uncontrolled cardiac, renal, hepatic, or other systemic disorders or significant psychological conditions that in the Investigator's judgment would jeopardize subject enrollment or compliance
  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: NCT00498914

Locations
United States, California
Beverly Hills, California, United States, 90211
Palo Alto, California, United States, 94305
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Miami, Florida, United States, 33136
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Louisiana
Shreveport, Louisiana, United States, 71130
United States, Missouri
St Louis, Missouri, United States, 63110
United States, North Carolina
Winston-Salem, North Carolina, United States, 27157
United States, Oregon
Portland, Oregon, United States, 97213
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Houston, Texas, United States, 77303
San Antonio, Texas, United States, 78229
Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L6
France
Bordeaux, France, 33076
Montpellier, France, 34295
Nantes, France, 44093
Nice, France, 06200
Poitiers, France, 86021
Rouen, France, 76038
Tours, France, 37044
Spain
Barcelona, Spain, 08035
Madrid, Spain, 28041
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Sr Manager Clinical Trial Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT00498914     History of Changes
Other Study ID Numbers: 155-CL-009, Eudra CT 2006-002584-70
Study First Received: July 10, 2007
Last Updated: May 8, 2009
Health Authority: United States: Food and Drug Administration
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
Lymphoma, Large-Cell, Diffuse
Lymphoma, B-Cell
YM155
Treatment outcomes
Refractory

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014