drugset / Trial / NCT02962401

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

NCT02962401 ↗

Phase 2 Completed 50 enrolled French Innovative Leukemia Organisation
NaSingle-groupOpen-labelTreatment

Summary

Prospective national multicenter open label phase II Remodel WM3 trial

Timeline

Start
2017-03-07
Primary completion
2020-08-31
Completion
2023-04-13

Outcome

Met primary endpoint

paper The primary endpoint was achieved with a median PFS of 25.4 months (95% CI, 15.7 to 29.0). PMID 39499299 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Idelalisib Small molecule 150 mg Oral
Subject Obinutuzumab Monoclonal antibody 1000 mg Intravenous