Study of Brentuximab Vedotin in Pediatric Patients with Lymphoma

• Research type

  Research Study

• Full title

  A Phase 1/2 Study of Brentuximab Vedotin (SGN-35) in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma

• IRAS ID

  84703

• Contact name

  Stephen Daw

• Sponsor organisation

  Millennium Pharmaceuticals Inc

• Eudract number

  2011-001240-29

• ISRCTN Number

  N/A

• Research summary

  Most patients diagnosed with systemic anaplastic large cell lymphoma (sALCL) or Hodgkins lymphoma (HL) respond to their initial chemotherapy regimens; however, 20-40% of these patients relapse, and approximately 10% of patients will have refractory disease. For these patients there is no standard treatment. Most of these patients will receive salvage chemotherapeutic regimens and stem cell transplantation, both of which are associated with significant morbidities. Using immunotherapy treatment, with an antibody drug conjugate (ADC), has shown therapeutic potential in adults with relapsed or refractory HL. Brentuximab vedotin is an antibody drug conjugate (ADC) with anti-tumour activity. Use of this therapy may maximise patient??s chance of complete remission. Patients in complete remission when undergoing stem cell transplantation have a markedly increase rate of prolonged survival. This study is the first clinical use of Brentuximab vedotin exclusively in pediatric patient with relapsed or refractory disease. The study aims to evaluate the safety, pharmacokinetics, immunogenicity and anti-tumour activity of Brentuximab vedotin.

• REC name

  North East - York Research Ethics Committee

• REC reference

  12/NE/0010

• Date of REC Opinion

  28 Feb 2012

• REC opinion

  Further Information Favourable Opinion