Purpose of this Study
This study begins with about one month of screening tests, such as blood tests and exams, to see if a person can join. If eligible, people will be placed into one of two groups by chance. One group will receive a medicine called lisaftoclax with another medicine called azacitidine. The other group will receive a placebo, which has no active medicine, along with azacitidine.
Treatment happens in cycles that last 28 days. During each cycle, lisaftoclax or placebo is taken by mouth for 14 days, and azacitidine is given by a shot or through a vein for 7 days. At the start, there will be more clinic visits, and visits may become less frequent over time. Participants will continue treatment as long as it is helping and side effects are manageable. After stopping treatment, there will be a follow up visit to check safety.
Who Can Participate?
Eligibility
People can join this study if they are adults who have a blood problem called higher risk myelodysplastic syndrome that was just diagnosed. They cannot have received treatment for this condition before. They also cannot be taking part in another research study at the same time.
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 lisaftoclax when it is used together with a standard treatment called azacitidine. Researchers want to see if adding the new medicine helps people more than using the standard treatment alone. They will look at whether the combination is safe, if it helps people live longer, and if it improves blood counts.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Global Multicenter, Double-Blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination with Azacitidine (AZA) in Patients with Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4)
Principal Investigator
Harry
Erba
Protocol Number
PRO00120001
NCT ID
NCT06641414
Phase
III
Enrollment Status
Pending Open to Enrollment