Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367374
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-20
Brief Title:
MRD Guided Sonrotoclax and Zanubrutinib in Newly Diagnosed CLLSLL
Sponsor:
Institute of Hematology Blood Diseases Hospital China
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
A Single Arm Open-label Study of MRD-Guided Zanubrutinib in Combination With Sonrotoclax in Adult Patients With Treatment Naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm open-label study of sonrotoclax plus zanubrutinib with MRD-driven treatment duration in patients with previously untreated Chronic Lymphocytic Leukemia CLL or Small Lymphocytic Lymphoma SLL
The primary goal of this study is to evaluate the efficacy of MRD-guided zanubrutinib plus sonrotoclax for first-line CLLSLL treatment
The primary goal of this study is to evaluate the efficacy of MRD-guided zanubrutinib plus sonrotoclax for first-line CLLSLL treatment
Detailed Description:
Chronic lymphocytic leukemia CLL and small lymphocytic lymphoma SLL are often considered different variations of the same disease due to their many similarities There is an urgent need for new treatments to improve patients quality of life prolong survival and manage disease-related symptoms
There are several different methods for treating front-line therapy including Chemoimmunotherapy CIT Bruton tyrosine kinase inhibitors BTKis and BCL-2 inhibitors BCL2is Continuous treatment with BTK inhibitors is necessary for the treatment of CLL or SLL However younger patients may need to limit their therapeutic duration The combination of BTK inhibitors and BCL-2 inhibitors is believed to be an optimizing regimen that provides a limited duration of therapy
The main aim of this study is to assess whether MRD-guided zanubrutinib in combination with sonrotoclax can be an effective first-line treatment option for adult patients with treatment-naïve CLL or SLL The goal is to achieve long-lasting and more profound responses which could allow for the possibility of discontinuing treatment
There are several different methods for treating front-line therapy including Chemoimmunotherapy CIT Bruton tyrosine kinase inhibitors BTKis and BCL-2 inhibitors BCL2is Continuous treatment with BTK inhibitors is necessary for the treatment of CLL or SLL However younger patients may need to limit their therapeutic duration The combination of BTK inhibitors and BCL-2 inhibitors is believed to be an optimizing regimen that provides a limited duration of therapy
The main aim of this study is to assess whether MRD-guided zanubrutinib in combination with sonrotoclax can be an effective first-line treatment option for adult patients with treatment-naïve CLL or SLL The goal is to achieve long-lasting and more profound responses which could allow for the possibility of discontinuing treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None