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

Phase 2
18 Years
Not Enrolling
Lymphoma, Large-Cell, Diffuse, Lymphoma, B-Cell Refractory

Thank you

Trial Information

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

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

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Overall response rate

Outcome Time Frame:

15 treatment cycles

Safety Issue:


Principal Investigator

Use Central Contact

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

April 2009

Related Keywords:

  • Lymphoma, Large-Cell, Diffuse
  • Lymphoma, B-Cell Refractory
  • Lymphoma, Large-Cell, Diffuse
  • Lymphoma, B-Cell
  • YM155
  • Treatment outcomes
  • Refractory
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse



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