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NCT03816319 · ClinicalTrials.gov registry record · Phase 1

TAK-243 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes With Increased Blasts

A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
42
Enrollment target
5
Study locations

NCT03816319 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 42 participants, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (11% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT03816319, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
42 participants
Enrollment target
5
Study locations

Study Summary

This phase I trial studies the side effects and best dose of TAK-243 in treating patients with acute myeloid leukemia or myelodysplastic syndromes with increased blasts that has come back (relapsed) or that is not responding to treatment (refractory). TAK-243 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Aspiration
  • PROCEDURE Bone Marrow Biopsy
  • PROCEDURE Echocardiography Test
  • PROCEDURE Multigated Acquisition Scan

Study Locations (5)

Florida

  • Moffitt Cancer Center - Tampa

Illinois

  • Northwestern University - Chicago

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Virginia

  • VCU Massey Comprehensive Cancer Center - Richmond

Ontario

  • University Health Network-Princess Margaret Hospital - Toronto

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2025-03-12
Est. Completion 2026-10-24
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT03816319

The ClinicalTrials.gov registry entry for NCT03816319 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 42 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 (11% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT03816319 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Florida, Illinois, Ohio.

Frequently Asked Questions

What is clinical trial NCT03816319 about?

NCT03816319 is a clinical study titled "TAK-243 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes With Increased Blasts". This phase I trial studies the side effects and best dose of TAK-243 in treating patients with acute myeloid leukemia or myelodysplastic syndromes with increased blasts that has come back (relapsed) or that is not responding to treatment (refractory). TAK-243 may stop the growth of cancer cells by b...

What is the current status of trial NCT03816319?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2025-03-12. Estimated completion is 2026-10-24.

What conditions does trial NCT03816319 study?

This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts.

What interventions are being tested in trial NCT03816319?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Echocardiography Test (PROCEDURE), Multigated Acquisition Scan (PROCEDURE).

Who is sponsoring clinical trial NCT03816319?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03816319 being conducted?

This trial has 5 study locations across Florida, Illinois, Ohio, Virginia, Ontario. 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.