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NCT06196203 · ClinicalTrials.gov registry record · Phase 2
A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
A Phase 2 study of Higher-risk Myelodysplastic Syndromes, sponsored by Akeso.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 15
- Study locations
NCT06196203: Recruiting Phase 2 study of Higher-risk Myelodysplastic Syndromes, sponsored by Akeso.
NCT06196203 is a Phase 2 study of Higher-risk Myelodysplastic Syndromes that is actively recruiting participants, run by Akeso. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). The trial reports 15 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06196203, a Phase 2 study of Higher-risk Myelodysplastic Syndromes, is actively recruiting participants, sponsored by Akeso.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 15
- Study locations
Study Summary
This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).
Primary Outcome
CRR is defined as the proportion of subjects with complete remission (CR) per International Working Group (IWG) 2023 criteria
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Azacitidine
- DRUG AK117
Study Locations (15)
Maryland
- American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda) - Bethesda
- Maryland Oncology-Columbia - Columbia
Ohio
- Gabrail Cancer Center - Canton
- Ohio State University - Columbus
California
- UCLA Ronald Reagan Medical Center - Los Angeles
Colorado
- Rocky Mountain Cancer Centers - Aurora
Connecticut
- Yale Cancer Center - New Haven
Florida
- Mid Florida Hematology and Oncology Center - Orange City
Missouri
- Washington University School of Medicine in St. Louis - St Louis
New York
- Montefiore Einstein Comprehensive Cancer Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2024-02-07 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What NCT06196203 shows while recruiting
NCT06196203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 1 condition, with Higher-risk Myelodysplastic Syndromes appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06196203 lists 15 locations in 13 states (Maryland, Ohio, California).
Frequently Asked Questions
What is clinical trial NCT06196203 about?
NCT06196203 is a clinical study titled "A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes". This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).
What is the current status of trial NCT06196203?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2024-02-07. Estimated completion is 2026-06.
What conditions does trial NCT06196203 study?
This clinical trial studies the following conditions: Higher-risk Myelodysplastic Syndromes.
What interventions are being tested in trial NCT06196203?
The interventions under investigation include: Placebo (DRUG), Azacitidine (DRUG), AK117 (DRUG).
Who is sponsoring clinical trial NCT06196203?
This trial is sponsored by Akeso, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06196203 being conducted?
This trial has 15 study locations across California, Colorado, Connecticut, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Higher-risk Myelodysplastic Syndromes
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 NCT06196203's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,200 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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