Clinical trial NCT00498914: Study of YM155 in Refractory Diffuse Large B-cell Lymphoma (DLBCL) Subjects
Official title: A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma, Large-Cell, Diffuse
Lymphoma, B-Cell Refractory
Keywords: Lymphoma, Large-Cell, Diffuse
Lymphoma, B-Cell
YM155
Treatment outcomes
Refractory
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-07-11
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: Overall response rate
timeFrame: 15 treatment cycles
Secondary outcomes:
measure: Safety, efficacy, pharmacokinetics, and tolerability
timeFrame: 15 treatment cycles
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Shreveport
country: United States
state: Louisiana
city: St Louis
country: United States
state: Missouri
city: Winston-Salem
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Ottawa
country: Canada
state: Ontario
city: Bordeaux
country: France
city: Montpellier
country: France
city: Nantes
country: France
city: Nice
country: France
city: Poitiers
country: France
city: Rouen
country: France
city: Tours
country: France
city: Barcelona
country: Spain
city: Madrid
country: Spain
Study officials:
affiliation: Astellas Pharma Global Development
name: Use Central Contact
role: STUDY_DIRECTOR
References: