Study on Lisaftoclax (APG-2575) and Azacitidine for Treating Higher-Risk Myelodysplastic Syndrome
Sponsor: Ascentage Pharma Group Inc.
ClinicalTrials ID:NCT06641414
This clinical trial is testing a new treatment combining Lisaftoclax (APG-2575) with azacitidine to see if it can improve survival in patients with higher-risk myelodysplastic syndrome (HR-MDS) compared to azacitidine alone.
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Program Overview
The purpose of this study is to determine if a new treatment using Lisaftoclax (APG-2575) combined with azacitidine can help patients with higher-risk myelodysplastic syndrome (HR-MDS) live longer compared to those receiving a placebo with azacitidine. This is a global study involving multiple centers and is designed to provide clear results on the effectiveness of the treatment.
Description
This study is enrolling patients who have been newly diagnosed with higher-risk myelodysplastic syndrome (HR-MDS). Participants will receive either the combination of Lisaftoclax (APG-2575) and azacitidine or a placebo with azacitidine. The goal is to see if the new combination treatment can improve overall survival rates in these patients. The study is conducted in a double-blind manner, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo, to ensure unbiased results.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed with higher-risk myelodysplastic syndrome (HR-MDS).
- Have an ECOG performance status score of 0, 1, or 2, indicating full activity or some restriction in physically strenuous activity.
- Expected to live for at least 3 more months.
- Have adequate organ function as determined by medical tests.
- Women who can become pregnant must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for six months after the last dose.
- Able to understand and sign a consent form agreeing to participate in the study.
- Able to complete all study procedures and attend follow-up visits.
Exclusion Criteria
- Have another active cancer or a history of cancer that has not been in remission for at least one year.
- Have had a stem cell transplant.
- Have an uncontrolled active infection.
- Are taking certain medications that affect liver enzymes within 7 days before starting the study.
- Have myelodysplastic syndrome or other conditions that prevent taking medication by mouth.
- Have any other condition that the study doctor believes makes participation inappropriate.
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