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RecruitingLast updated: 17 April 2026

GLORA-4: Targeted therapy plus chemotherapy for people with newly diagnosed, higher-risk myelodysplastic syndrome (HR-MDS)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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

GLORA-4

Clinical summary

Summary

This study intends to enrol people with newly diagnosed higher risk myelodysplastic syndrome (HR-MDS) to receive treatment with the targeted drug Lisaftoclax combined with azacitidine chemotherapy, or placebo combined with azacitidine.

Eligible participants will be randomly allocated (by chance) to receive either:

  • Lisaftoclax (gven orally, once daily) + azacitidine (given as an injection, once daily)
  • Placebo (given orally, once daily) + azacitidine (given as an injection, once daily)

Conditions

This trial is treating people with newly diagnosed, higher-risk myelodysplastic syndrome

Eligibility

Inclusion

  1. Newly diagnosed higher-risk MDS.
  2. ECOG score of ≤2.
  3. Expected survival ≥ 3 months.
  4. Adequate organ function.
  5. Female subjects of potential childbearing potential have a negative urine or serum pregnancy test before dosing. Subjects of childbearing potential as well as their partners voluntarily use contraception deemed effective by the investigator during the treatment period and for at least six months after the last dose of study drug.
  6. 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.
  7. Subjects are able to complete study procedures and follow-up examinations.

Exclusion

  1. Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent.
  2. Have undergone hematopoietic stem cell transplantation.
  3. Uncontrolled active infection
  4. Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.
  5. MDS or other conditions that cannot be administered enterally.
  6. Any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You are able to swallow medication by mouth.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Ascentage Pharma Group Inc.

Scientific 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)

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