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

Stopped early · Phase 2

Conditions studied: Lymphoma, Large-Cell, Diffuse, Lymphoma, B-Cell Refractory

In brief

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

Key facts

Study ID

NCT00498914

Run by

Astellas Pharma Inc

People needed

41

Starts

2007-06-01

Expected to finish

2009-04-01

Last updated by the study team

2015-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Beverly Hills, California, United States
• Study site — Palo Alto, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Shreveport, Louisiana, United States
• Study site — St Louis, Missouri, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Ottawa, Ontario, Canada
• Study site — Bordeaux, France
• Study site — Montpellier, France
• Study site — Nantes, France
• Study site — Nice, France
• Study site — Poitiers, France
• Study site — Rouen, France
• Study site — Tours, France
• Study site — Barcelona, Spain
• Study site — Madrid, Spain

Full record on ClinicalTrials.gov

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