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

Lymphoma, Large-Cell, Diffuse Clinical Trial

Official title:

A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00498914
• Other study ID #: 155-CL-009
• Secondary ID: Eudra CT 2006-00
• Status: Terminated
• Phase: Phase 2
• First received: July 10, 2007
• Last updated: August 20, 2015
• Start date: June 2007
• Est. completion date: April 2009

Study information

• Verified date: August 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSpain: Spanish Agency of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory AgencyCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, B-Cell Refractory
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Large-Cell, Diffuse

Intervention

Drug:
• YM155
Continuous IV infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  Canada,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		15 treatment cycles	No
Secondary	Safety, efficacy, pharmacokinetics, and tolerability		15 treatment cycles	No