Anti-CCR4 Monoclonal Antibody KW-0761 in patients with ATL

• Research type

  Research Study

• Full title

  Multi-Center, Open-Label, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 versus Investigator’s Choice in Subjects with Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)

• IRAS ID

  108701

• Contact name

  Paul Fields

• Contact email

  Paul.Fields@gstt.nhs.uk

• Sponsor organisation

  Kyowa Kirin Pharmaceutical Development

• Eudract number

  2011-005738-20

• Clinicaltrials.gov Identifier

  NCT01611142

• Research summary

  This international, multi-center, open-label, randomized study will enroll subjects with confirmed diagnosis of Acute T-Cell Leukaemia-Lymphoma (ATL) who are relapsed or refractory after at least one prior systemic therapy regimen. Subjects will be randomized 2:1 to receive the study drug, KW-0761 or Investigator's choice of pralatrexate, GemOx or DHAP. These are chemotherapy regimes. In the UK, pralatrexate has not been licensed so will not be an available option. Patients will continue on the study drug or investigator's choice until they show progression of disease or unacceptable side effects. Patients who are randomised to Investigator's choice may cross over to KW0761 when disease progression occurs.

• REC name

  West of Scotland REC 1

• REC reference

  12/WS/0184

• Date of REC Opinion

  18 Sep 2012

• REC opinion

  Further Information Favourable Opinion