NCT02677324

Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia

Phase II Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a targeted therapy as a possible treatment for relapsed or refractory Waldenstrom's Macroglobulinemia (WM). This study is using the study intervention ABT-199.

Detailed description

This research study is a Phase II clinical trial. ABT-199 is a pill that blocks BCL-2, a protein that is important for the survival of WM cells. The purpose of this research study is to evaluate how well the study drug works and the safety of ABT-199 as a single agent in participants with WM that has come back or has shown no response to previous treatment. The FDA (the U.S. Food and Drug Administration) has not approved ABT-199 as a treatment for any disease.

Conditions

• Waldenstrom Macroglobulinemia

Interventions

Type	Name	Description
DRUG	ABT199	Oral BCL-2 antagonist

Timeline

• Start date: 2016-05-09
• Primary completion: 2020-02-14
• Completion: 2022-02-07
• First posted: 2016-02-09
• Last updated: 2022-05-11
• Results posted: 2021-05-11

Locations

4 sites across 1 country: United States