Pixantrone in the treatment of Non Hodgkin Lymphoma (2)

• Research type

  Research Study

• Full title

  A Randomized Multicenter Study Comparing Pixantrone + Rituximab with Gemcitabine + Rituximab in Patients with Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed after Therapy with CHOP-R or an Equivalent Regimen and are Ineligible for Stem Cell Transplant

• IRAS ID

  118431

• Contact name

  Ruth Pettengell

• Sponsor organisation

  Cell Therapeutics, Inc.

• Eudract number

  2012-001790-86

• Clinicaltrials.gov Identifier

  NCT01321541

• Research summary

  This study compares the research drug pixantrone given with rituximab to gemcitabine given with rituximab for the ability to improve survival in patients with aggressive B-Cell non-Hodgkin lymphoma (either diffuse large B-cell lymphoma or follicular grade 3 lymphoma) and have relapsed and are not eligible for a stem cell transplant. There is no standard treatment for patients who are not candidates for intensive second line therapies or who have relapsed more than once after standard treatments. Pixantrone is a novel compound related to anthracyclines. 350 patients are being recruited globally, including 4 hospitals in the UK. Eligible patients will be randomly assigned to treatment with pixantrone plus rituximab or gemcitabine plus rituximab in up to six 28-day cycles. After treatment, there is a 2 1/2 year follow up period with visits every 8-12 weeks. All patients will then continue to be monitored for survival.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  12/EM/0453

• Date of REC Opinion

  24 Dec 2012

• REC opinion

  Further Information Favourable Opinion