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NCT03755414 · ClinicalTrials.gov registry record · Phase 1

Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

A Phase 1 study of Myelodysplastic Syndromes and Non-Hodgkin Lymphoma, sponsored by Washington University School of Medicine.

Completed
Registry status
Phase 1
Development phase
55
Enrollment target
1
Study location

NCT03755414 is a Phase 1 study of Myelodysplastic Syndromes and Non-Hodgkin Lymphoma that has completed, run by Washington University School of Medicine. The registered enrollment target is 55 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03755414, a Phase 1 study of Myelodysplastic Syndromes and Non-Hodgkin Lymphoma, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
55 participants
Enrollment target
1
Study location

Study Summary

In this trial, the investigators will begin to explore the possibility that, as in mice, janus kinase inhibitor 1 (JAK1) inhibition with haploidentical-hematopoietic cell transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) and cytokine release syndrome (CRS) while retaining Graft-versus-Leukemia (GVL) and improving engraftment. The purpose of this pilot study is to determine the safety of itacitinib with haplo-hematopoietic cell transplantation (HCT) measured by the effect on engraftment and grade III-IV GVHD.

Interventions

  • DRUG Itacitinib
  • PROCEDURE Stem cell transplantation
  • OTHER Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
  • OTHER Human Activity Profile

Study Locations (1)

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2019-09-04
Est. Completion 2024-05-26
Phase Phase 1

What the Registry Record Tells You About NCT03755414

The ClinicalTrials.gov registry entry for NCT03755414 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (81% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 4 interventions - of which Itacitinib is the first listed.

NCT03755414 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT03755414 about?

NCT03755414 is a clinical study titled "Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation". In this trial, the investigators will begin to explore the possibility that, as in mice, janus kinase inhibitor 1 (JAK1) inhibition with haploidentical-hematopoietic cell transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) and cytokine release syndrome (CRS) while retaining Graft-ver...

What is the current status of trial NCT03755414?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2019-09-04. Estimated completion is 2024-05-26.

What conditions does trial NCT03755414 study?

This clinical trial studies the following conditions: Myelodysplastic Syndromes, Non-Hodgkin Lymphoma, Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Hodgkin Disease.

What interventions are being tested in trial NCT03755414?

The interventions under investigation include: Itacitinib (DRUG), Stem cell transplantation (PROCEDURE), Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) (OTHER), Human Activity Profile (OTHER).

Who is sponsoring clinical trial NCT03755414?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03755414 being conducted?

This trial has 1 study location across Missouri. 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

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