Purpose of this Study
In this study, people are placed into one of two groups based on certain features found in their genes. The first group, called Cohort 1, includes people who have low‑risk genetic signs. To be in this group, a person must have a mutated IGHV gene, must not have a 17p deletion, and must not have a TP53 mutation. All three conditions must be true. People in this group will first take a medicine called acalabrutinib for two cycles. After that, they will take a combination of acalabrutinib and venetoclax, called AV, for twelve more cycles.
The second group, called Cohort 2, includes people who have any high‑risk genetic signs. This may include having an unmutated IGHV gene, a 17p deletion, a TP53 mutation, or a mix of these.
Who Can Participate?
Eligibility
To join this study, a person must be at least 18 years old. They must have a type of cancer called CLL or SLL, based on special medical rules. They must have already had their first treatment that used certain medicines together and must have improved from that treatment. At least two years must have passed since they finished that first treatment.
Before starting the study, the researchers need information about the person’s genes, including whether the IGHV gene is mutated, whether there is a 17p deletion, and whether there is a TP53 mutation. The person must also be healthy enough to take part, which means they must be able to move and do daily activities and must have strong enough blood counts. This includes having enough neutrophils, platelets, and hemoglobin, either at normal levels or slightly lower if the cancer affects the bone marrow.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study wants to learn more about how well two medicines, acalabrutinib and venetoclax, work together for people whose disease got worse after they first responded well to earlier treatment. These people will first take acalabrutinib alone for two cycles. After that, they will take both acalabrutinib and venetoclax together for twenty‑two more cycles. Altogether, they will receive twenty‑four cycles of treatment.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
AstraZeneca AB: The MAVRiC Study: A Phase II Study of Disease Risk Mutation-guided Finite Duration Acalabrutinib plus Venetoclax for Relapse in CLL/SLL after First-line Finite covalent BTKi plus BCL2i combination, with or without Obinutuzumab
Principal Investigator
Danielle
Brander
Protocol Number
PRO00118960
NCT ID
NCT07024706
Phase
II
Enrollment Status
Open to Enrollment