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NCT04620681 · ClinicalTrials.gov registry record · Phase 1
CD8 Depleted, Non-engrafting, HLA Mismatched Unrelated Infusion With MDS and Secondary AML
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT04620681: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT04620681 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04620681, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of the study is to determine the safety of an investigational treatment for myelodysplastic syndrome (MDS) after the first therapy (such as azacitidine or decitabine) stops working or after progression of MDS to acute myeloid leukemia (AML). Funding source - FDA OOPD.
Primary Outcome
Maximum Tolerated Dose will be determined by testing increasing doses of CD8 depleted non-engrafting HLA-mismatched unrelated donor lymphocytes infusion (NE-DLI).
Interventions
- DRUG Standard of Care Chemotherapy
- BIOLOGICAL CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-01-14 |
| Est. Completion | 2024-07-20 |
| Phase | Phase 1 |
What the finished NCT04620681 record still lists
NCT04620681 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care Chemotherapy is the first listed.
NCT04620681 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04620681 about?
NCT04620681 is a clinical study titled "CD8 Depleted, Non-engrafting, HLA Mismatched Unrelated Infusion With MDS and Secondary AML". The purpose of the study is to determine the safety of an investigational treatment for myelodysplastic syndrome (MDS) after the first therapy (such as azacitidine or decitabine) stops working or after progression of MDS to acute myeloid leukemia (AML). Funding source - FDA OOPD.
What is the current status of trial NCT04620681?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2021-01-14. Estimated completion is 2024-07-20.
What interventions are being tested in trial NCT04620681?
The interventions under investigation include: Standard of Care Chemotherapy (DRUG), CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT04620681?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04620681's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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