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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 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.

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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.

Conditions Studied

Refractory Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia Blasts 10 Percent or More of Bone Marrow Nucleated Cells Allogeneic Stem Cell Transplant Recipient

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

6 total trials

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What the Registry Record Tells You About NCT04220684

The ClinicalTrials.gov registry entry for NCT04220684 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (60% lower). The listed sponsor is Sumithira Vasu, which has 6 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.