NCT02962401

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

An Open Label Non-randomized Phase II Study Exploring "Chemo-free " Treatment Association With Idelalisib + Obinutuzumab in Patient With Relapsed/Refractory Waldenstrom's Macroglobulinemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: French Innovative Leukemia Organisation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective national multicenter open label phase II Remodel WM3 trial

Detailed description

An Open Label non-randomized Phase II Study exploring chemo-free treatment association with Idelalisib and Obinutuzumab in Patient with relapsed refractory Waldenstrom's Macroglobulinemia

Conditions

• Waldenstrom Macroglobulinemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-03-07
• Primary completion: 2020-08-31
• Completion: 2023-04-13
• First posted: 2016-11-11
• Last updated: 2023-08-29

Locations

1 site across 1 country: France