Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
NCT ID:
NCT01007292
Eligibility 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 \</= 1
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01007292
Study Brief:
Protocol Section:
NCT01007292