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NCT07646821 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b/2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in Newly Diagnosed MDS/AML (≥ 10% Blasts) With TP53 Mutations
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Not yet
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT07646821: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT07646821 is a Phase 1 study that has not yet begun recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07646821, a Phase 1 study, has not yet begun recruiting, sponsored by M.D. Anderson Cancer Center.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
To find the recommended dose of ropeginterferon alfa-2b in combination with azacitidine in patients with newly diagnosed MDS/AML with TP53 mutations. To learn if the recommended dose of ropeinterferon alfa-2b found in Dose Escalation in combination with azacitidine can help to control the disease.
Primary Outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Interventions
- DRUG Azacitidine (AZA)
- DRUG ropeginterferon alfa- 2b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-11-27 |
| Est. Completion | 2030-12-11 |
| Phase | Phase 1 |
What is known before NCT07646821 opens enrollment
NCT07646821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Azacitidine (AZA) is the first listed.
NCT07646821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07646821 about?
NCT07646821 is a clinical study titled "A Phase 1b/2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in Newly Diagnosed MDS/AML (≥ 10% Blasts) With TP53 Mutations". To find the recommended dose of ropeginterferon alfa-2b in combination with azacitidine in patients with newly diagnosed MDS/AML with TP53 mutations. To learn if the recommended dose of ropeinterferon alfa-2b found in Dose Escalation in combination with azacitidine can help to control the disease.
What is the current status of trial NCT07646821?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-11-27. Estimated completion is 2030-12-11.
What interventions are being tested in trial NCT07646821?
The interventions under investigation include: Azacitidine (AZA) (DRUG), ropeginterferon alfa- 2b (DRUG).
Who is sponsoring clinical trial NCT07646821?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07646821's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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