A study investigating the efficacy and safety of copanlisib versus placebo inpatients with rituximab-refratory indolent non-Hodgkin's lymphoma. Copanlisib nell’iNHL di Fase III refrattario a r...

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Reference: EUCTR2014-000925-19

A study investigating the efficacy and safety of copanlisib versus placebo inpatients with rituximab-refratory indolent non-Hodgkin's lymphoma. Copanlisib nell’iNHL di Fase III refrattario a rituximab

Woman and Man

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Extract

to investigate whether copanlisib as monotherapy is superior to placebo in prolonging progression-free survival (PFS) in patients with rituximab-refractory iNHL who have received two or more prior lines of treatment, have been exposed to rituximab and alkylating agent(s), and have progressed within six months of the end of the last previous rituximab-containing regimen Valutare se copanlisib in monoterapia sia superiore al placebo nel prolungare la sopravvivenza libera da progressione (PFS) in pazienti affetti da iNHL refrattario a rituximab che hanno ricevuto due o più linee precedenti di trattamento, sono stati esposti a rituximab ed ad agenti alchilanti e sono progrediti entro sei mesi dalla conclusione dell’ultimo regime precedente contenente rituximab (modificato secondo emendamento 1)


Inclusion criteria

  • Rituximab-refractory indolent non-Hodgkin's lymphoma,Linfoma non-Hodgkin indolente a B-cellule recidivato