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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
N/A
Not Enrolling
Both
Lymphoma, Large-Cell, Diffuse, Lymphoma, B-Cell Refractory

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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
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

Type of Study:

Interventional

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:

No

Principal Investigator

Use Central Contact

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

155-CL-009

NCT ID:

NCT00498914

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

Name

Location

Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Metairie, Louisiana  70006
Denver, Colorado  
Charlotte, North Carolina  
Eugene, Oregon