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Trial Title:
Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).
NCT ID:
NCT06641414
Condition:
Higher-risk Myelodysplastic Syndrome
Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes
Syndrome
Azacitidine
Conditions: Keywords:
Higher-risk Myelodysplastic Syndrome
Lisaftoclax
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Lisaftoclax (APG-2575)
Description:
QD, oral administration.
Arm group label:
Lisaftoclax (APG-2575) combined with Azacitidine
Intervention type:
Drug
Intervention name:
Azacitidine Injection
Description:
QD, hypodermic or intravenous injection.
Arm group label:
Lisaftoclax (APG-2575) combined with Azacitidine
Arm group label:
Placebo combined with Azacitidine
Intervention type:
Other
Intervention name:
Placebo
Description:
QD, oral administration.
Arm group label:
Placebo combined with Azacitidine
Summary:
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.
Detailed description:
This study intends to enroll patients with HR-MDS to receive the therapy of Lisaftoclax
(APG-2575) combined with azacitidine (AZA) or placebo combined with azacitidine.
Criteria for eligibility:
Criteria:
Inclusion 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.
Exclusion Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77054
Country:
United States
Contact:
Last name:
Guillermo Garcia-Manero, M.D.
Phone:
713-745-3428
Email:
ggarciam@mdanderson.org
Investigator:
Last name:
Guillermo Garcia-Manero, M.D.
Email:
Principal Investigator
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Zip:
100033
Country:
China
Contact:
Last name:
Xiaojun Huang, M.D.,Ph.D.
Phone:
010-88325229
Email:
xjhrm@medmail.com.cn
Investigator:
Last name:
Xiaojun Huang, M.D.,Ph.D.
Email:
Principal Investigator
Start date:
October 2024
Completion date:
December 2029
Lead sponsor:
Agency:
Ascentage Pharma Group Inc.
Agency class:
Industry
Source:
Ascentage Pharma Group Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06641414
