Study of Brentuximab Vedotin in Patients With R/R PTCL Treated With Gemcitabine
Condition: Refractory Peripheral T-Cell Lymphoma; Relapsed Peripheral T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is an open label, multicenter phase 2 study. The primary objective of the study is
      to determine the efficacy of brentuximab vedotin in patients treated by gemcitabine for
      relapsed or refractory peripheral T-cell lymphoma in term of overall response rate assessed
      after 4 cycles of treatment according to the international response criteria for malignant
      lymphoma (Lugano Classification 2014 - CT-Based Response).
    

Detailed description: 
      Currently, there is no standard treatment for patients with recurrent or refractory
      peripheral T-cell lymphoma who relapse after a first line of cyclophosphamide,
      hydroxydaunomycin, oncovin, and prednisone (CHOP) treatment.

      Chemotherapies such as gemcitabine are used as monotherapy but the results alone are
      insufficient. In addition, there is no approved monotherapy in the European Union, with the
      exception of brentuximab vedotin in refractory or recurrent large systemic anaplastic
      lymphomas.

      Stem cell transplantation may be an option for patients who respond to a second line of
      treatment or a subsequent line of treatment, but conditions for being eligible for
      transplantation, including long-term remission, are infrequent.

      Brentuximab vedotin (BV) is a targeted treatment directed against a protein, cluster of
      differentiation antigen 30 (CD30), present on the surface of lymphoma cells. It allows
      chemotherapy to enter directly into the lymphoma cell. The CD30 protein is variably expressed
      in patients with relapsed or refractory T-cell lymphoma; about 50% of patients have
      significant expression.

      Data from clinical studies with brentuximab vedotin suggest that the addition of this
      treatment to gemcitabine may be more successful than gemcitabine alone.

      The main hypothesis is a 15% increase in responder patients after 4 cycles of treatment with
      brentuximab vedotin and gemcitabine. The main objective of the study is therefore to
      determine the overall response rate after 4 cycles of treatment according to the criteria of
      Lugano 2014 (response based on CT-scan).

      The secondary objectives will focus on the efficacy of brentuximab vedotin: complete response
      rate, response time for responder patients, time to failure of treatment, time to next
      treatment and overall survival, efficacy of brentuximab vedotin maintenance: survival
      progression-free, response time, overall survival, overall response rate based on positron
      emission tomography (PET)-scan and brentuximab vedotin toxicity in patients treated with
      gemcitabine and in maintenance therapy.

      The duration of the study is estimated to be 4.5 years including follow-up with an estimated
      recruitment period of 1.5 years. 70 patients will be enrolled.
    

Intervention name(s): Brentuximab Vedotin - induction; Gemcitabine; Brentuximab Vedotin - maintenance; autologous or allogeneic stem cell transplantation
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention description(s): Brentuximab vedotin 1.8 mg/kg at D8 of a 28-day cycle - 4 cycles = 16 weeks for combined chemotherapy; Gemcitabine 1000 mg/m² at D1 and D15 of a 28-day cycle - 4 cycles = 16 weeks for combined chemotherapy; Patients who will obtain partial or complete response and who will not be eligible for transplant will receive maintenance therapy with brentuximab vedotin every 3 weeks for 12 infusions.
Brentuximab vedotin 1.8 mg/kg at D1 of a 21-day cycle - 12 cycles = 36 weeks for maintenance therapy; Patients who will obtain partial or complete response and who will be eligible for transplant will receive autologous or allogeneic stem cell transplantation
Other intervention name(s): Adcetris; Gemzar; Adcetris
Intervention MeSH terms: Gemcitabine; Brentuximab Vedotin; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Intervention model description: This study is an open label, multicenter phase 2 study. Patients treated with gemcitabine will receive brentuximab vedotin (GBv) for 4 cycles of induction.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brentuximab Vedotin; T-cell lymphoma