RECRUITING

Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).

Conditions

Higher-risk Myelodysplastic Syndrome Lisaftoclax

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. placebo combined with azacitidine in newly diagnosed patients with HR-MDS.

Official 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).

Quick Facts

Study Start:2025-01-22

Study Completion:2029-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06641414

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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.	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 7 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 Criteria

Exclusion Criteria

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.

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 7 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.

Contacts and Locations

Study Contact

Yifan Zhai, M.D., Ph.D.

CONTACT

+86-20-28068501

yzhai@ascentage.com

Qian Niu, M.D.

CONTACT

Qian.Niu@ascentage.com

Principal Investigator

Xiaojun Huang, M.D., Ph.D.

STUDY_CHAIR

Peking University People's Hospital

Guillermo Garcia-Manero, M.D.

STUDY_CHAIR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77054

United States

Collaborators and Investigators

Sponsor: Ascentage Pharma Group Inc.

Xiaojun Huang, M.D., Ph.D., STUDY_CHAIR, Peking University People's Hospital
Guillermo Garcia-Manero, M.D., STUDY_CHAIR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-22

Study Completion Date2029-12

Study Record Updates

Study Start Date2025-01-22

Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

Higher-risk Myelodysplastic Syndrome
Lisaftoclax

Additional Relevant MeSH Terms

Higher-risk Myelodysplastic Syndrome