Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637501
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Open-Label Phase 2 Study to Investigate the Efficacy and Safety of Sonrotoclax Combined With Zanubrutinib Compared With Zanubrutinib Monotherapy in Adult Patients With Previously Untreated Chronic Lymphocytic Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
The purpose of this study is to support the registration plan of sonrotoclax plus zanubrutinib treatment in participants with previously untreated CLL This study is designed to assess the contribution of sonrotoclax to the efficacy outcome of the combination of zanubrutinib and sonrotoclax
Detailed Description:
This study will test how effective and safe sonrotoclax plus zanubrutinib treatment compared with zanubrutinib alone in participants with previously untreated chronic lymphocytic leukemia CLL
The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment and to determine what adverse events or side effects patients might experience
Sonrotoclax is an experimental drug that works by blocking a protein called B-cell lymphoma-2 Bcl-2 This protein helps certain types of blood tumor cells to survive and grow When sonrotoclax blocks Bcl-2 it slows down or stops the growth of tumor cells and helps them die This can lead to improvements in patients with CLL disease
Zanubrutinib is a commercialized product that works by blocking a protein called Brutons tyrosine kinase BTK and controlling the activity and survival of malignant B cells Zanubrutinib has received approval in over 65 countriesregions worldwide for the treatment of adult participants with B cell malignancies including CLL
The study will enroll approximately 87 participants who will be randomly assigned by a computer program to receive one of the following treatments sonrotoclax zanubrutinib or zanubrutinib
The study will take place at multiple centers worldwide The overall time to participate in this study is approximately 5 years
The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment and to determine what adverse events or side effects patients might experience
Sonrotoclax is an experimental drug that works by blocking a protein called B-cell lymphoma-2 Bcl-2 This protein helps certain types of blood tumor cells to survive and grow When sonrotoclax blocks Bcl-2 it slows down or stops the growth of tumor cells and helps them die This can lead to improvements in patients with CLL disease
Zanubrutinib is a commercialized product that works by blocking a protein called Brutons tyrosine kinase BTK and controlling the activity and survival of malignant B cells Zanubrutinib has received approval in over 65 countriesregions worldwide for the treatment of adult participants with B cell malignancies including CLL
The study will enroll approximately 87 participants who will be randomly assigned by a computer program to receive one of the following treatments sonrotoclax zanubrutinib or zanubrutinib
The study will take place at multiple centers worldwide The overall time to participate in this study is approximately 5 years
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