Phase II Trial GA101 Inbrutinib B CLL

Update Il y a 4 ans
Reference: NCT02666898

Woman and Man

  • | Country :
  • -
  • | organs :
  • -
  • | Specialty :
  • -

Extract

Phase II study testing chemo-free induction therapy with Ibrutinib + Obinutuzumab nine months / Study Part 1: All patients will receive 8 courses of GA101 + ibrutinib 420mg PO every 28 days Study Part 2: After evaluation at D1 of month 9: If patients are in CR with BM MRD < 10-4, they will continue ibrutinib alone at a dose of 420mg daily If patients have BM MRD >10-4 whatever IWCLL 2008 responses or PR they will receive four courses of GA101 + FC at 28-day intervals + Ibrutinib PO until final evaluation of M16


Inclusion criteria

  • Leukemia Lymphocytic Chronic B-Cell

Links