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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00498914
Recruitment Status : Terminated (Futility boundary at interim analysis not met)
First Posted : July 11, 2007
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Lymphoma, Large-Cell, Diffuse Lymphoma, B-Cell Refractory Drug: YM155 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2007
Primary Completion Date : April 2009
Study Completion Date : April 2009


Arm Intervention/treatment
Experimental: 1 Drug: YM155
Continuous IV infusion



Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 15 treatment cycles ]

Secondary Outcome Measures :
  1. Safety, efficacy, pharmacokinetics, and tolerability [ Time Frame: 15 treatment cycles ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00498914     History of Changes
Other Study ID Numbers: 155-CL-009
Eudra CT 2006-002584-70
First Posted: July 11, 2007    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: August 2015

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

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