YM155 plus Rituximab in CD-20 positive B cell non-hodgkin's lymphoma

• Research type

  Research Study

• Full title

  A Phase II, Multicenter, Open-Label Study Of YM155 Plus Rituximab In Previously Treated Subjects With CD20-Positive B Cell Non-Hodgkin’s Lymphoma Who Are Ineligible For Or Have Previously Received An Autologous Stem Cell Transplant

• IRAS ID

  37200

• Contact name

  Christian Hatton

• Sponsor organisation

  Astellas Pharma Global Development, Inc. (APGD)

• Eudract number

  2009-010777-20

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT01007292

• Research summary

  This is a Phase II Multicenter, open-label study of YM155 plus rituximab in previously treated subjects with CD20 positive B cell Non-Hodgkin??s Lymphoma (NHL) who are ineligible for or have previously received an Autologous Stem Cell Transplant. Approximately 196,298 new cases of NHL were reported worldwide in 2007. NHL is an aggressive cancer and the patient may have continuous relapses. The purpose of this study is to evaluate if YM155 plus rituximab is safe and if this combination can either shrink tumours or stop them from growing. To be eligible to take part in this trial amongst other factors patients must be aged 18 years or older at the Baseline Visit and must have relapsed following receipt of last dose of systemic chemotherapy or autologous stem cell transplant (ASCT). Approximately 60 patients in North America and Europe will be treated with the combination of YM155 and rituximab in this study. Patients will be given YM155 and rituximab during 14 day cycles. Each subject will be assessed at the end of each cycle to determine if he or she may continue to the next cycle. Each subject will be eligible to continue receiving the combination regimen in this study until one of the discontinuation criteria is met. If a subject discontinues treatment without progressive disease (PD) that subject will complete follow-up visits every 12 weeks for 1 year or until initiating another systemic anti-lymphoma treatment, exhibiting PD, or death. Each subject will be contacted by the study site every 12 weeks for survival following the End of Treatment Visit. The contacts will continue until death or for no more than 1 year.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  10/H0406/16

• Date of REC Opinion

  27 Apr 2010

• REC opinion

  Further Information Favourable Opinion