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NCT04628338 · ClinicalTrials.gov registry record · Early Phase 1
IFN-γ to Treat Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) That Has Relapsed After Allogeneic Hematopoietic Stem Cell Transplantation
A Early Phase 1 study, sponsored by Sawa Ito, MD.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
NCT04628338: Completed Early Phase 1 study, sponsored by Sawa Ito, MD.
NCT04628338 is a Early Phase 1 study that has completed, run by Sawa Ito, MD. The registered enrollment target is 8 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04628338, a Early Phase 1 study, has completed, sponsored by Sawa Ito, MD.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study proposes a safe dosing regimen IFN-γ that is sufficient to stimulate IFN-γ receptors on malignant blasts in patients who developed relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after alloSCT with no active or history of III-IV acute graft-versus-host disease (GVHD). It is hypothesized that IFN-γ will promote graft-vs-leukemia (GVL) in patients with AML/MDS that has relapsed after alloSCT.
Primary Outcome
Upregulation of HLA l (HLA-ABC) in bone marrow malignant blasts post-IFN-γ treatment, measured by the change in mean florescent intensity by flow cytometry.
Interventions
- DRUG IFN-γ (interferon gamma-1b) injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-03-08 |
| Est. Completion | 2023-10-30 |
| Phase | Early Phase 1 |
What the finished NCT04628338 record still lists
NCT04628338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which IFN-γ (interferon gamma-1b) injection is the first listed.
NCT04628338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04628338 about?
NCT04628338 is a clinical study titled "IFN-γ to Treat Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) That Has Relapsed After Allogeneic Hematopoietic Stem Cell Transplantation". This study proposes a safe dosing regimen IFN-γ that is sufficient to stimulate IFN-γ receptors on malignant blasts in patients who developed relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after alloSCT with no active or history of III-IV acute graft-versus-host disease (GVH...
What is the current status of trial NCT04628338?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2021-03-08. Estimated completion is 2023-10-30.
What interventions are being tested in trial NCT04628338?
The interventions under investigation include: IFN-γ (interferon gamma-1b) injection (DRUG).
Who is sponsoring clinical trial NCT04628338?
This trial is sponsored by Sawa Ito, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04628338's enrollment target sits among peer trials
8 1783rd of 2000 higher than 176 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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