Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06520098
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-02-12
Brief Title:
A Randomized Phase II Study Of Bruton Tyrosine Kinase Inhibitor With Or Without Venetoclax In Veterans With Chronic Lymphocytic Leukemia CLLSmall Lymphocytic Lymphoma SLL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Benefit of Venetoclax Addition Benefit VA in Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma CLLSLL
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:
Benefit VA
Brief Summary:
People who have chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL are often treated with ibrutinib acalabrutinib or zanubrutinib These are pills that are taken by mouth This type of pill is called Bruton Tyrosine Kinase Inhibitor or BTKi Another treatment for CLLSLL is a different pill called venetoclax
The purpose of this study is to compare continuing the current treatment with BTKi alone as long as it is working to another arm of treatment which adds venetoclax to the current treatment BTKi for one year After one year both pills in this arm of treatment would be stopped and the participants will be closely monitored
The purpose of this study is to compare continuing the current treatment with BTKi alone as long as it is working to another arm of treatment which adds venetoclax to the current treatment BTKi for one year After one year both pills in this arm of treatment would be stopped and the participants will be closely monitored
Detailed Description:
People who have chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL are often treated with ibrutinib acalabrutinib or zanubrutinib These are pills that are taken by mouth This type of pill is called a Bruton Tyrosine Kinase Inhibitor or BTKi Another treatment for CLLSLL is a different pill called venetoclax
People with CLLSLL who are currently taking BTKi as their treatment must continue to take the medicine for the rest of their lives unless it is no longer working or causing difficult side effects
New studies tested the combination of BTKi and venetoclax for one to two years and showed that it was a very effective treatment and allowed patients to stop therapy
The investigators dont know if adding venetoclax in patients who have already taken BTKi therapy for at least six months and who are responding to it will help control the CLLSLL better and if it will allow them to stop treatment safely Also the investigators dont know how the side effects and effectiveness of the combination will be in Veterans The investigators also dont know how a patients quality of life will be affected if they continue BTKi by itself or if they take the combination and then are able to stop treatment
If participants meet the eligibility criteria they will be randomly assigned a study treatment This study has 2 main study groups
ARM A BTKI ALONE There will be about 50 people in this group
ARM B BTKI PLUS VENETOCLAX There will be about 50 people in this group
The participants will not be charged for any treatments or procedures that are part of this study If participants usually pay co-payments for VA care and medications they will still pay these co-payments for VA care and medications that are not part of this study
People with CLLSLL who are currently taking BTKi as their treatment must continue to take the medicine for the rest of their lives unless it is no longer working or causing difficult side effects
New studies tested the combination of BTKi and venetoclax for one to two years and showed that it was a very effective treatment and allowed patients to stop therapy
The investigators dont know if adding venetoclax in patients who have already taken BTKi therapy for at least six months and who are responding to it will help control the CLLSLL better and if it will allow them to stop treatment safely Also the investigators dont know how the side effects and effectiveness of the combination will be in Veterans The investigators also dont know how a patients quality of life will be affected if they continue BTKi by itself or if they take the combination and then are able to stop treatment
If participants meet the eligibility criteria they will be randomly assigned a study treatment This study has 2 main study groups
ARM A BTKI ALONE There will be about 50 people in this group
ARM B BTKI PLUS VENETOCLAX There will be about 50 people in this group
The participants will not be charged for any treatments or procedures that are part of this study If participants usually pay co-payments for VA care and medications they will still pay these co-payments for VA care and medications that are not part of this 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