Phase III study of Brentuximab vedotin in T-cell lymphoma patients

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled, phase 3 study of brentuximab vedotin and CHP (A+CHP) versus CHOP in the frontline treatment of patients with CD30-positive mature T-cell lymphomas

• IRAS ID

  114825

• Contact name

  Tim Illidge

• Eudract number

  2012-002751-42

• Research summary

  PHASE 3 STUDY TO EVALUATE HOW EFFECTIVE AND SAFE THE ADDITION OF BRENTUXIMAB IS WHEN ADDED TO STANDARD TREATMENT FOR PATIENTS WITH MATURE T-CELL LYMPHOMA (MTCL).The aim of this study is to investigate whether brentuximab vedotin (study medication), when added to the standard treatment for patients with MTCL can improve the patient??s survival. MTCL is a type of cancer of the body??s immune system. The standard of care for these patients is treatment with a combination of drugs called CHOP [cyclophosphamide, doxorubicin, vincristine and prednisone]. The study medication will be added in the standard treatment combination to replace vincristine (Aࡳ). About 300 patients will take part in this study at approximately 130 sites in North America, Europe, and Asia. In the UK, the study will take place in specialist cancer centres. Study treatment consists of 6-8 21-day cycles of either CHOP or Aࡳ. The maximum total duration of therapy is 8 cycles, or approximately 6 months. After a participant has stopped getting study treatment, he/she will have follow up visits and/or follow-up phone calls every 3-6 months until the study is closed. The study is expected to stay open for about 7 years from the time the first patient is treated. The participants will be assigned by chance to either the standard or the experimental treatment combination and will have a 50-50 chance to receive the study medication. Neither the participant, nor the study team will know what type of treatment the participant will be receiving. This study will consist of screening, treatment, end of treatment and survival follow-up phases. The participants will have to undergo blood tests, scans, biopsies, physical examinations and other procedures.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  13/NW/0006

• Date of REC Opinion

  18 Feb 2013

• REC opinion

  Further Information Favourable Opinion