BAY80-6946/17833 (CHRONOS-4) (R/R)

BAY80-6946/17833 (CHRONOS-4) (R/R)

A phase III, randomized, double-blind, controlled multicenter study of intravenous PI3K inhibitor Copanlisib with standard immunochemotherapy versus standard immunochemotherapy in patients with relapsed indolent non-Hodgkin's lymphoma (iNHL) (CHRONOS-4)


Study treatments

Experimental arm
Combination of copanlisib with standard immunochemotherapy (rituximab and bendamustine (R-B) or rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP))
Copanlisib + R-B
28-day cycle

Copanlisib
(IV* on days 1,8,15)
Rituximab
(IV 375 mg/m² on day 1)
Bendamustine
(IV 90 mg/m² on days 1 and 2)



Copanlisib + R-CHOP
21-day cycle

Copanlisib
(IV on days 1,8)
Rituximab
(IV 375 mg/m² on day 2)
Cyclophosphamide
(IV 750 mg/m² on day 2)
doxorubicin
(IV 50 mg/m² on day 2)
vincristine
(IV 1,4 mg/m² on day 2)
prednisone
(oral 100 mg on days 2-6)
Placebo comparator
Combination of placebo with standard immunochemotherapy (rituximab and bendamustine (R-B) or rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP))
Placebo + R-B
28-day cycle

Placebo
(IV on days 1,8,15)
Rituximab
(IV 375 mg/m² on day 1)
Bendamustine
(IV 90 mg/m² on days 1 and 2)



Placebo + R-CHOP
21-day cycle

Placebo
(IV on days 1,8)
Rituximab
(IV 375 mg/m² on day 2)
Cyclophosphamide
(IV 750 mg/m² on day 2)
doxorubicin
(IV 50 mg/m² on day 2)
vincristine
(IV 1,4 mg/m² on day 2)
prednisone
(oral 100 mg on days 2-6)

*intravenous


Inclusion criteria


Exclusion criteria


Participating sites

Link