SGN35-011 Brentuximab vedotin in patients with ALC Lymphoma

• Research type

  Research Study

• Full title

  A Phase 1 Study of Brentuximab Vedotin administered sequentially and concurrently with Multi-Agent Chemotherapy as Front-Line treatment in patients with CD30-Positive Mature T-Cell and NK-Cell Neoplasms, including Systemic Anaplastic Large Cell Lymphoma

• IRAS ID

  71280

• Contact name

  Tim Illidge

• Sponsor organisation

  Seattle Genetics, Inc.

• Eudract number

  2010-022839-11

• Research summary

  This is a Phase 1 open-label, multicentre study in patients with systemic anaplastic large cell lymphoma (ALCL) which is a rare disease that accounts for 2%??5% of all cases of adult non-Hodgkin lymphomas (NHL). Patients with systemic ALCL have a poor prognosis and approximately 40??65% of patients develop recurrent disease. The study is designed to assess the safety profile and maximum tolerated dose (MTD) of brentuximab vedotin, an antibody-drug conjugate, which induces cell cycle arrest and results in apoptotic death of tumour cells.There will be two parts and three arms in this study. In Arm 1 of the first part of the study the safety and activity of brentuximab vedotin administered prior to the initiation of CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone) will be evaluated. In Arm 2 of the first part of the study the maximum tolerated does (MTD) of brentuximab vedotin when delivered in combination with CHOP will be determined. Patients will be concurrently enrolled in Arms 1 and 2 during the first part of the study. The second part of the study will commence after the MTD from Arm 2 has been established and all patients enrolled in Arm 2 have completed at least one cycle of dosing. The second part of the study is designed to further evaluate the safety and activity of brentuximab vedotin when administered before, during, and after CHOP chemotherapy (Arm 3).

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/NW/0039

• Date of REC Opinion

  5 Apr 2011

• REC opinion

  Further Information Favourable Opinion