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NCT04220684 · ClinicalTrials.gov registry record · Phase 1
Trial Testing Safety of IL-21 NK Cells for Induction of R/R AML
A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by Sumithira Vasu.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 2
- Study locations
NCT04220684: Completed Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by Sumithira Vasu.
NCT04220684 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia that has completed, run by Sumithira Vasu. The registered enrollment target is 19 participants, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (60% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04220684, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, has completed, sponsored by Sumithira Vasu.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I trial studies the side effects of donor natural killer (NK) cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or has not responded to treatment (refractory). Natural killer cells are a type of immune cell. Immunotherapy with genetically modified NK cells from donors may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread.
Primary Outcome
The MTD will be defined as the highest safely tolerated dose where at most one patient in six experiences dose-limiting toxicity (DLT) during DLT observation period. DLT is defined as any steroid refractory acute graft versus host disease.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Cytarabine Hydrochloride
- BIOLOGICAL Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells
Study Locations (2)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2020-06-11 |
| Est. Completion | 2024-10-22 |
| Phase | Phase 1 |
What the finished NCT04220684 record still lists
NCT04220684 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 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (60% lower).
The record links to 4 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Fludarabine is the first listed.
NCT04220684 reports a single indexed study location in Ohio, Oregon.
Frequently Asked Questions
What is clinical trial NCT04220684 about?
NCT04220684 is a clinical study titled "Trial Testing Safety of IL-21 NK Cells for Induction of R/R AML". This phase I trial studies the side effects of donor natural killer (NK) cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or has not responded to treatment (refractory). Natural killer cells are a type of immune cell. Immunotherapy with genetically modifie...
What is the current status of trial NCT04220684?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2020-06-11. Estimated completion is 2024-10-22.
What conditions does trial NCT04220684 study?
This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Blasts 10 Percent or More of Bone Marrow Nucleated Cells, Allogeneic Stem Cell Transplant Recipient.
What interventions are being tested in trial NCT04220684?
The interventions under investigation include: Fludarabine (DRUG), Cytarabine Hydrochloride (DRUG), Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT04220684?
This trial is sponsored by Sumithira Vasu, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04220684 being conducted?
This trial has 2 study locations across Ohio, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Acute Myeloid Leukemia
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 NCT04220684's enrollment target sits among peer trials
19 50th of 63 higher than 14 of 63 other Refractory Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Acute Myeloid Leukemia 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.
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