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COMPLETED Phase 1

Trial Testing Safety of IL-21 NK Cells for Induction of R/R AML

NCT04220684 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 19 participants
Start Date 2020-06-11
Est. Completion 2024-10-22
Phase Phase 1

Sponsor

Sumithira Vasu

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04220684

The ClinicalTrials.gov registry entry for NCT04220684 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumithira Vasu, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04220684 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Ohio, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04220684?

This trial is sponsored by Sumithira Vasu, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial