Titre An Open-Label, Multicenter, Phase I Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of BTCT4465A, WITH OR WITHOUT SINGLE-DOSE OBINUTUZUMAB PRETREATMENT, in Patients with Relapsed or Refractory B Cell Non-Hodgkin’s Lymphoma (FL and DLBCL)
Protocole ID GO29781
ClinicalTrials.gov ID NCT02500407
Type(s) de cancer Lymphome non-hodgkinien (LNH)
Phase Phase I
Stade Maladie réfractaire
Type étude Traitement
Médicament BTCT4465A et Obinutuzumab
Institution CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
   HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
      3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
Ville Montréal
Investigateur(trice) principal(e) Dre Sarit Assouline
Coordonnateur(trice) Amine Saad
514-340-8222 poste 24599
Statut Actif en recrutement
Critètes d'éligibilité
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • B-cell lymphoma expected to express the cluster of differentiation 20 (CD20) antigen who have relapsed after or failed to respond to at least one prior treatment regimen and for whom there is no available therapy expected to improve survival
  • Adequate hepatic, hematologic, and renal function
Critètes d'exclusion
  • Pregnant or lactating women
  • Monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, chemotherapy, or other investigational anti-cancer agent within 4 weeks prior to study drug
  • Treatment with radiotherapy within 2 weeks prior to the first BTCT4465A administration
  • Systemic immunosuppressive medication within 2 weeks prior to study drug
  • Autologous stem cell transplantation (SCT) within 100 days prior to study drug, or any prior allogeneic SCT or solid organ transplantation
  • Autoimmune disease with the exception of controlled/treated hypothyroidism, disease-related immune thrombocytopenic purpura, or hemolytic anemia
  • History of central nervous system (CNS) lymphoma or other CNS disease
  • Significant cardiovascular or pulmonary disease
  • Hepatitis B or C or human immunodeficiency virus (HIV)
  • Receipt of a live attenuated vaccine within 4 weeks prior to study drug