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NCT04167696 · ClinicalTrials.gov registry record · Phase 1

Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02

A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Celyad Oncology.

Recruiting
Registry status
Phase 1
Development phase
27
Enrollment target
5
Study locations

NCT04167696 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by Celyad Oncology. The registered enrollment target is 27 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (77% lower). The trial reports 5 study locations across 3 states.

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The verdict

NCT04167696, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by Celyad Oncology.

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

Study Summary

An open-label, phase I, multi-center study to determine in relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-02 consolidation cycle for non-progressive patient. A maximum of 27 r/r AML/MDS patients will be evaluated in this study in case of no dose limiting toxicity (DLT) and no replacement of patients.

Conditions Studied

Acute Myeloid Leukemia Myelodysplastic Syndrome

Interventions

  • BIOLOGICAL CYAD-02
  • DRUG ENDOXAN
  • DRUG Fludara

Study Locations (5)

Other

  • Uz Leuven - Leuven
  • Chu Liege - Liège
  • AZ DELTA - Roeselare

Florida

  • Mayo Clinic Cancer Center - Jacksonville

Kansas

  • University of Kansas Cancer Center - Fairway

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2019-11-25
Est. Completion 2035-02
Phase Phase 1

Sponsor

Celyad Oncology

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04167696

The ClinicalTrials.gov registry entry for NCT04167696 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (77% lower). The listed sponsor is Celyad Oncology, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which CYAD-02 is the first listed.

NCT04167696 reports 5 study locations spanning 3 distinct geographic areas - top geographies include Other, Florida, Kansas.

Frequently Asked Questions

What is clinical trial NCT04167696 about?

NCT04167696 is a clinical study titled "Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02". An open-label, phase I, multi-center study to determine in relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-02 consolidation cycle for ...

What is the current status of trial NCT04167696?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2019-11-25. Estimated completion is 2035-02.

What conditions does trial NCT04167696 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome.

What interventions are being tested in trial NCT04167696?

The interventions under investigation include: CYAD-02 (BIOLOGICAL), ENDOXAN (DRUG), Fludara (DRUG).

Who is sponsoring clinical trial NCT04167696?

This trial is sponsored by Celyad Oncology, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04167696 being conducted?

This trial has 5 study locations across Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.