Purpose of this Study
The study has 4 parts: screening, taking the study drug, stopping the drug, and follow-up. You’ll get tests like blood work, heart checks, and scans. You’ll be randomly given one of two medicines: BGB-16673 or Pirtobrutinib, both taken once a day. After stopping the medicine, you’ll return for a check-up in about a month. If your cancer hasn’t gotten worse, you’ll visit every 6 months. If it has, the study team will check on you by phone or email. The whole study may last about 3 years with around 13 visits.
Who Can Participate?
Eligibility
Who can join the study:
- Adults with a type of blood cancer called CLL or SLL who need treatment.
- They must have had certain treatments before and still have signs of the disease.
Who cannot join the study:
- People with other serious blood cancers or brain problems.
- People who had certain types of transplants or treatments recently.
- People with serious allergies to the study medicine.
- People with infections or bleeding problems.
- People who had a stroke or brain bleeding in the last 6 months.
- People who take certain blood-thinning medicines or have HIV.
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
Doctors are doing a study to test two new medicines called BGB-16673 and Pirtobrutinib. They want to find out which one works better and is safer for people who have a type of blood cancer called CLL or SLL and have already had treatment before.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
BeOne Medicines Ltd. / ?A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Principal Investigator
Andrea
Sitlinger
Protocol Number
PRO00118734
NCT ID
NCT06973187
Phase
III
Enrollment Status
Pending Open to Enrollment