CHEMO-T

• Research type

  Research Study

• Full title

  Cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) versus gemcitabine, cisplatin and methyl prednisolone (GEM-P) in the first line treatment Of T-cell Lymphoma, a multicentre randomised phase II study

• IRAS ID

  80305

• Contact name

  David Cunningham

• Sponsor organisation

  The Royal Marsden NHS Foundation Trust

• Eudract number

  2011-004146-18

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  T-cell lymphomas are a rare and heterogeneous group comprising of around 10- 15% of all lymphomas. Approximately 1000-1500 cases are diagnosed each year in the UK. There are no randomized trials of chemotherapy in T-cell lymphoma and currently, there is no internationally accepted standard regimen. Despite this, CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) chemotherapy regimen is widely used for first-line treatment of this disease, with generally poor outcomes. The GEM-P regimen (gemcitabine, cisplatin and methyl prednisolone) has also shown activity in patients with T-cell lymphoma and has been used at a number of UK centres with encouraging results. The CHEMO-T trial is a randomised, open-label phase 2 study that will compare CHOP chemotherapy regimen with GEM-P regimen in the first line treatment of T-cell lymphoma. The primary end-point for this study will be the end of treatment metabolic complete response rate as assessed by the PET scan. Approximately, 186 patients will be recruited to the study, which wil be carried out at multiple centres across the United Kingdom.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  11/LO/1570

• Date of REC Opinion

  14 Oct 2011

• REC opinion

  Favourable Opinion