NCT04115059

Dasatinib In Waldenström Macroglobulinemia

Dasatinib in Patients With Waldenström Macroglobulinemia (WM) Progressing on Ibrutinib

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Jorge J. Castillo, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is Phase I pilot, single center study designed to explore the safety of Dasatinib in symptomatic Waldenström Macroglobulinemia participants who are progressing on ibrutinib therapy with BTK Cys481 or PLCG2 mutations

Detailed description

This research study is a Pilot Study, which is the first time investigators are examining this drug in patients with Waldenström Macroglobulinemia who have progressed on ibrutinib. Patients who fulfill eligibility criteria will be entered into the trial to receive Dasatinib After the screening procedures confirm participation in the research study: The participant will be given a study drug-dosing calendar for each treatment cycle. In this research study, the investigators are planning to give Dasatinib, which is a targeted therapy intended to treat cancer by binding to the target protein called BTK. * BTK is believed to be an important target for treatment of patients with specific gene mutations. Some patients who have disease progression after taking ibrutinib have these gene mutations. * Making treatment decisions based on genetic testing is investigational, and the FDA has not approved this genetic testing. The U.S. Food and Drug Administration (FDA) has not approved Dasatinib for Waldenström Macroglobulinemia but it has been approved for other uses. Dasatinib is produced by Bristol-Myers Squibb.

Conditions

• Waldenstrom Macroglobulinemia
• DASATINIB

Interventions

Type	Name	Description
DRUG	Dasatinib	Oral, daily, dosing per protocol, once a day for cycle

Timeline

• Start date: 2019-11-04
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-10-03
• Last updated: 2024-03-21
• Results posted: 2024-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study