C25003 Ph3 A+AVD vs ABVD Frontline in Patients with Hodgkin Lymphoma

• Research type

  Research Study

• Full title

  A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

• IRAS ID

  117042

• Contact name

  Graham Collins

• Sponsor organisation

  Millennium Pharmaceuticals, Inc

• Eudract number

  2011-005450-60

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  Advances in the use of combination chemotherapy and radiotherapy have dramatically improved the outcomes for Hodgkin Lymphoma (HL) patients. However, following frontline combination therapy relapse is observed in up to 35% of advanced-stage cases. Consequently, more effective frontline treatments are required.Brentuximab vedotin is a novel antibody-drug conjugate with anti-tumour activity (directed against the CD30 surface antigen). Brentuximab vedotin is approved in the United States and Europe as ADCETRIS for the treatment of patients with HL after failure of autologous stem cell transplant (ASCT), or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and for the treatment of patients with systemic anaplastic large cell lymphoma after failure of at least 1 prior multi-agent chemotherapy regimen.In these settings, brentuximab vedotin shows impressive response rates in very high risk patients when used as a single agent. Early studies show that this drug is effective and safe in first line treatment for HL when used in addition to the three drugs commonly used for frontline therapy (known by the acronym AVD). This study is an open-label, randomised, 2-arm, multicentre, phase 3 study. The aim is to compare the current standard of care for frontline treatment of advanced Hodgkin Lymphoma (ABVD) with AVD combined with brentuximab vedotin (AŐ). The study treatment will be given for up to 6 cycles. Each cycle is made up of 28 days, and dosing will be given on both day 1 and day 15 of each 28-day cycle. Approximately 1,040 patients at approximately 150 centres worldwide will participate in this study.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/1950

• Date of REC Opinion

  20 Feb 2013

• REC opinion

  Further Information Favourable Opinion