Study of YM155 in Refractory Diffuse Large B-cell Lymphoma (DLBCL) Subjects
NCT ID: NCT00498914
Last Updated: 2015-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
41 participants
INTERVENTIONAL
2007-06-30
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
YM155
Continuous IV infusion
Interventions
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YM155
Continuous IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Beverly Hills, California, United States
Palo Alto, California, United States
Aurora, Colorado, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Shreveport, Louisiana, United States
St Louis, Missouri, United States
Winston-Salem, North Carolina, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
San Antonio, Texas, United States
Ottawa, Ontario, Canada
Bordeaux, , France
Montpellier, , France
Nantes, , France
Nice, , France
Poitiers, , France
Rouen, , France
Tours, , France
Barcelona, , Spain
Madrid, , Spain
Countries
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Other Identifiers
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Eudra CT 2006-002584-70
Identifier Type: -
Identifier Source: secondary_id
155-CL-009
Identifier Type: -
Identifier Source: org_study_id
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