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RECRUITING Phase 3

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

NCT06641414 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 490 participants
Start Date 2025-01-22
Est. Completion 2029-12
Phase Phase 3

Sponsor

Ascentage Pharma Group

98 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06641414

The ClinicalTrials.gov registry entry for NCT06641414 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 490 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ascentage Pharma Group, which has 98 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06641414 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Texas, Beijing Municipality. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06641414?

The interventions under investigation include: Placebo (OTHER), Lisaftoclax (APG-2575) (DRUG), Azacitidine Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06641414?

This trial is sponsored by Ascentage Pharma Group, which has 98 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial