Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561347
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Zanubrutinib Bendamustine Rituximab Prev Untreated WM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Multicenter Study of the Combination Zanubrutinib Bendamustine and Rituximab in Previously Untreated Waldenström Macroglobulinemia ZEBRA Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZEBRA
Brief Summary:
The purpose of this study is to determine the very good partial response VGPR or better rate in participants with Waldenström macroglobulinemia WM
The names of the study drugs involved in this study are as follows zanubrutinib bendamustine and rituximab
The names of the study drugs involved in this study are as follows zanubrutinib bendamustine and rituximab
Detailed Description:
This is multi-center phase 2 of zanubrutinib bendamustine and rituximab ZBR in previously untreated Waldenström macroglobulinemia WM
A phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease Investigational means that the drug is being studied
The US Food and Drug Administration FDA has not approved bendamustine and rituximab for your specific disease but it has been approved for other uses
The US FDA has approved zanubrutinib as a treatment option for your disease
The combination of zanubrutinib bendamustine and rituximab is not approved regimen for Waldenström macroglobulinemia WM and is investigational in this study
Participation is expected for a maximum of 15 cycles and follow-up for up to 5 years
It is expected that about 50 people will take part in this research study
A phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease Investigational means that the drug is being studied
The US Food and Drug Administration FDA has not approved bendamustine and rituximab for your specific disease but it has been approved for other uses
The US FDA has approved zanubrutinib as a treatment option for your disease
The combination of zanubrutinib bendamustine and rituximab is not approved regimen for Waldenström macroglobulinemia WM and is investigational in this study
Participation is expected for a maximum of 15 cycles and follow-up for up to 5 years
It is expected that about 50 people will take part in this research study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None