Efficacity of Idelalisib and Obinutuzumab in Patient With Relapsed Refractory Waldenstrom's Macroglobulinemia

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 7, 2017

Primary Completion Date

August 31, 2020

Study Completion Date

April 13, 2023

Conditions
Waldenstrom Macroglobulinemia
Interventions
DRUG

Obinutuzumab

"6 cycles every 28 days Cycle 1 :Obinutuzumab 1000mg I.V.(2 parts) 100mg day 1 and 900mg day 2 day 1, 8 and 15~Cycle 2 - 6 :~Obinutuzumab 1000mg I.V.day 1"

DRUG

Idelalisib

"6 cycles every 28 days~Cycle 1 :~Idelalisib 150 mg x 2 p.o. day 1 to 28 Cycle 2 - 6 Idelalisib 150 mg x 2 p.o. day 1 to 28 Consolidation Idelalisib alone 150 mg twice a day until day 672 = 2 years after the beginning of the treatment"

Trial Locations (1)

37044

Project manager, Tours

All Listed Sponsors
lead

French Innovative Leukemia Organisation

OTHER

NCT02962401 - Efficacity of Idelalisib and Obinutuzumab in Patient With Relapsed Refractory Waldenstrom's Macroglobulinemia | Biotech Hunter | Biotech Hunter