Phase2/3 of masitinib+dexamethasone & gemcitabine in TCell lymphoma v1

• Research type

  Research Study

• Full title

  A multicenter, randomised, open-label, three-parallel groups, phase 2-3 study to evaluate the efficacy and safety of masitinib with dexamethasone, gemcitabine with dexamethasone and the combination of masitinib, gemcitabine and dexamethasone in patients with relapsed or refractory peripheral T-cell lymphoma.

• IRAS ID

  147421

• Contact name

  Anne Lennard

• Contact email

  Anne.Lennard@nuth.nhs.uk

• Sponsor organisation

  AB Science

• Eudract number

  2010-021091-28

• Clinicaltrials.gov Identifier

  113,719, IND; 3215, NCRN Ref

• Research summary

  Lymphoma is the most common blood cancer.The two main forms of lymphoma are Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). Lymphoma occurs when cells of the immune system called lymphocytes, a type of white blood cell, grow and multiply uncontrollably.Peripheral T-cell lymphomas (PTCL) account for 15% of all non-Hodgkin lymphomas (NHL). T-cell lymphomas are generally considered aggressive and require systemic chemotherapy. Most patients with PTCL have disease that has spread to other organs or lymph nodes. Patients with relapsed or refractory T-cell lymphoma have a poor prognosis with a median overall survival of 14 months and a progression free survival of 3-4 months. There is currently no drug approved for this population in Europe and patients are currently treated using conventional chemotherapy (ie gemcitabine).
  Considering the high medical need, the study is proposed to evaluate masitinib in patients with relapsed or refractory T-cell lymphoma based on the main following arguments:
  • T-cell lymphoma express PDGF receptor in around 80% of cases
  • Masitinib inhibits PDGFR receptor, the Lyn tyrosine kinase and the Fyn tyrosine kinase, involved in proliferation and dissemination of cancer cells
  • Masitinib sensitises cell lines to gemcitabine in vitro
  • Preliminary experiences in dogs are promising

  The aim of the study is to evaluate the efficacy and safety of masitinib in two experimental arms of 85 patients per cohort: in combination with dexamethasone in one arm and in combination together with gemcitabine and dexamethasone in another.
  As very limited data are currently available in this population and, in order to evaluate the benefit/risk of the two experimental arms, a “control” group of 85 patients with combination of gemcitabine and dexamethasone alone has been added.
  In conclusion, this phase 2-3 study evaluating masitinib +/- gemcitabine is a proof of concept study and will permit to evaluate the benefit/risk of these new therapeutic options in patients with relapsed/refractory T-cell lymphoma.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  14/YH/1056

• Date of REC Opinion

  29 Jul 2014

• REC opinion

  Further Information Favourable Opinion