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NCT06641414 · ClinicalTrials.gov registry record · Phase 3
Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).
A Phase 3 study of Higher-risk Myelodysplastic Syndrome, sponsored by Ascentage Pharma Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 490
- Enrollment target
- 2
- Study locations
NCT06641414: Recruiting Phase 3 study of Higher-risk Myelodysplastic Syndrome, sponsored by Ascentage Pharma Group.
NCT06641414 is a Phase 3 study of Higher-risk Myelodysplastic Syndrome that is actively recruiting participants, run by Ascentage Pharma Group. The registered enrollment target is 490 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06641414, a Phase 3 study of Higher-risk Myelodysplastic Syndrome, is actively recruiting participants, sponsored by Ascentage Pharma Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 490 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
The primary endpoint was overall survival (OS), defined as the time from the date of randomization to the date of death of any cause.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Lisaftoclax (APG-2575)
- DRUG Azacitidine Injection
Study Locations (2)
Texas
- MD Anderson Cancer Center - Houston
Beijing Municipality
- Peking University People's Hospital - Beijing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 490 participants |
| Start Date | 2025-01-22 |
| Est. Completion | 2029-12 |
| Phase | Phase 3 |
What NCT06641414 shows while recruiting
NCT06641414 is an interventional study that assigns participants to a tested intervention. The registered 490 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Higher-risk Myelodysplastic Syndrome appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06641414 reports a single indexed study location in Texas, Beijing Municipality.
Frequently Asked Questions
What is clinical trial NCT06641414 about?
NCT06641414 is a clinical study titled "Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).". 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.
What is the current status of trial NCT06641414?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 490 participants. The study started on 2025-01-22. Estimated completion is 2029-12.
What conditions does trial NCT06641414 study?
This clinical trial studies the following conditions: Higher-risk Myelodysplastic Syndrome.
What interventions are being tested in trial NCT06641414?
The interventions under investigation include: Placebo (OTHER), Lisaftoclax (APG-2575) (DRUG), Azacitidine Injection (DRUG).
Who is sponsoring clinical trial NCT06641414?
This trial is sponsored by Ascentage Pharma Group, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06641414 being conducted?
This trial has 2 study locations across Texas, Beijing Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Higher-risk Myelodysplastic Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06641414's enrollment target sits among peer trials
490 782nd of 2000 higher than 1,219 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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