A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate response rate, survival, safety and tolerability of YM155 given in combination with rituximab in subjects with Non-Hodgkin's Lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Any stage, histologically confirmed CD20-positive primary or transformed diffuse large B cell lymphoma (DLBCL)or grade 3 follicular lymphoma (FL)

• Ineligible for or have previously received an autologous stem cell transplant (ASCT)

• Relapsed following receipt of the last dose of systemic chemotherapy or ASCT

• At least one prior chemotherapy regimen. Prior chemotherapy regimen must have contained anthracycline (unless contraindicated)

• If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period

• Eastern Cooperative Oncology Group (ECOG) performance status Exclusion Criteria:

• Use of any standard/experimental anti-lymphoma drug therapy within 21 days of the Baseline Visit

• Use of systemic steroids within 5 days of the Baseline Visit (except for the purposes of pre-medication prior to study regimen treatment)

• Prior allogeneic stem cell transplant (SCT)

• The subject has been previously treated with YM155

• The subject has known human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibody

• The subject has received other investigational therapy or procedures within 21 days prior to the first study drug administration