Purpose of this Study
This study has three parts called screening, treatment, and follow up. During screening, doctors will do tests to see if a person can join the study. If eligible, participants will be placed into one of two groups by chance. One group will take a medicine called rocbrutinib, and the other group will take a medicine called pirtobrutinib. Both medicines are taken by mouth once each day.
During the study, participants will have regular clinic visits, blood tests, and scans to check their health and see how the cancer is responding. They can continue taking the study medicine as long as it is helping and side effects are manageable. After treatment ends, doctors will continue to check on participants for several years through follow up visits and phone calls.
Who Can Participate?
Eligibility
People can join this study if they are 18 years old or older and have a blood cancer called chronic lymphocytic leukemia or small lymphocytic lymphoma. Their cancer must have come back after treatment or did not respond to treatment. They must have previously received a type of cancer medicine called a BTK inhibitor. Researchers are studying new treatment options to learn if they can better control the cancer and improve patient outcomes.
Age Range
18-100
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 is testing a new medicine called rocbrutinib and comparing it to an approved medicine called pirtobrutinib. The study is for people who have a blood cancer called chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back or did not respond to earlier treatment. Researchers want to learn which medicine does a better job of controlling the cancer and which one is safer for patients. They also want to understand more about how these medicines work in the body.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 3 Open-Label, Randomized, Multicenter Study of Rocbrutinib (LP-168) vs Pirtobrutinib in Covalent BTK Inhibitor (cBTKi) Pretreated Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) Subjects
Principal Investigator
Danielle
Brander
Protocol Number
PRO00120603
NCT ID
NCT07342478
Phase
III
Enrollment Status
Pending Open to Enrollment