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New treatment option for Higher-risk Myelodysplastic Syndrome
Official title Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).
ClinicalTrials.gov ID: NCT06641414
What this study is testing
What is Lisaftoclax (APG-2575)?
Lisaftoclax (APG-2575) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for higher-risk myelodysplastic syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A global multicenter, randomized, double-blind, placebo-controlled, pivotal phase III study. To evaluate overall survival (OS) of Lisaftoclax (APG-2575) combined with azacitidine (AZA) vs.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Newly diagnosed higher-risk MDS.
- ECOG score of ≤2.
- Expected survival ≥ 3 months.
- Adequate organ function.
- Female people of potential childbearing potential have a negative urine or serum pregnancy test before dosing. people of childbearing potential as...
You likely can't join if
- Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent.
- Have undergone hematopoietic stem cell transplantation.
- Uncontrolled active infection
- Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.
- MDS or other conditions that cannot be administered enterally.
- Any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.
See the full eligibility criteria
- Newly diagnosed higher-risk MDS.
- ECOG score of ≤2.
- Expected survival ≥ 3 months.
- Adequate organ function.
- Female people of potential childbearing potential have a negative urine or serum pregnancy test before dosing. people of childbearing potential as well as their partners voluntarily use contraception deemed effective by...
- Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of any trial-specified study procedures.
- people are able to complete study procedures and follow-up examinations.
- Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent.
- Have undergone hematopoietic stem cell transplantation.
- Uncontrolled active infection
- Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.
- MDS or other conditions that cannot be administered enterally.
- Any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.