Zevalin in patients with Diffuse Large B-cell Lymphoma

• Research type

  Research Study

• Full title

  A Phase 3, Open-label, Multicenter, Randomized Study of Sequential Zevalin (ibritumomab tiuxetan) versus Observation in Patients at Least 60 Years of Age with Newly Diagnosed Diffuse Large B-cell Lymphoma in PET-negative Complete Remission After R-CHOP or R-CHOP-like Therapy

• IRAS ID

  106785

• Contact name

  Timothy Illidge

• Sponsor organisation

  Spectrum Pharmaceuticals, Inc.

• Eudract number

  2011-004916-51

• Clinicaltrials.gov Identifier

  NCT01510184

• Research summary

  This is a prospective, multicentre, open label, randomised, two arm, phase 3 study, where patients are randomised to receive an additional study treatment of radiommunotherapy with the study drug 90Y Ibritumomab ??Zevalin? or undergo observation. This study will include patients, at least 60 years old, with the commonest type of Non-Hodgkin lymphoma (NHL), an aggressive cancer called diffuse large B-cell lymphoma (DLBCL). DLBCL comprises over a third of all newly diagnosed NHL cases. The current standard first line therapy for patients with DLBCL is a combination of chemotherapy drugs called R-CHOP or rituximab cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP). At the completion of this treatment it is established practice to assess the response to therapy with a PET CT scan. Patients with a complete response or CR, are eligible to be randomised into the trial. Around a third of PET negative patients will go onto relapse and die of their disease. The study drug is called 90Y Ibritumomab tiuxetan or ??Zevalin?, a type of treatment called ??radioimmunotherapy?, licensed for the treatment of other NHL since 2004. This involves a radioactive material, called yttrium 90, attached to an antibody targeting radiation to the malignant B cells. Altogether 490 patients will be randomly assigned (1:1) to observation or to receive the standard Zevalin regimen. Patients randomised to Zevalin will receive 2 infusions of 250mg/m2 rituximab, one week apart (Day 1, Day 7-9), followed by 10 minute push Y90 Zevalin within 4 hours of the second rituximab dose. Patients randomised to the observation arm will not receive any further therapy unless they have a relapse of their disease. Following the 13 week safety monitoring period following randomisation, patients will be followed up for 5 years post-randomisation, every 3 months up to 2 years, then no less than every 6 months to 5 years.

• REC name

  Wales REC 2

• REC reference

  12/WA/0164

• Date of REC Opinion

  26 Jun 2012

• REC opinion

  Further Information Favourable Opinion