Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-25 @ 1:26 AM
Study NCT ID:
NCT04115059
Status:
TERMINATED
Last Update Posted:
2024-03-21
First Post:
2019-10-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dasatinib In Waldenström Macroglobulinemia
Sponsor:
Jorge J. Castillo, MD
Organization:
Study Overview
Official Title:
Dasatinib in Patients With Waldenström Macroglobulinemia (WM) Progressing on Ibrutinib
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: