Trial Search Results

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

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Astellas Pharma Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: YM155

Phase:

Phase 2

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Office Office
6504987061
Not Recruiting