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NCT03513328 · ClinicalTrials.gov registry record · Phase 1

Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation

A Phase 1 study, sponsored by University of Florida.

Completed
Registry status
Phase 1
Development phase
6
Enrollment target

NCT03513328 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 6 participants.

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The verdict

NCT03513328, a Phase 1 study, has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study Summary

In this study, the investigators test 2 dose levels of thiotepa (5 mg/kg and 10 mg/kg) added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG) to determine the minimum effective dose required for reliable engraftment for subjects undergoing hematopoietic stem cell transplantation for non-malignant disease.

Interventions

  • DRUG Thiotepa--single daily dose
  • DRUG Thiotepa--escalated dose

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2018-06-15
Est. Completion 2023-02-19
Phase Phase 1

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT03513328

The ClinicalTrials.gov registry entry for NCT03513328 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Thiotepa--single daily dose is the first listed.

NCT03513328 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03513328 about?

NCT03513328 is a clinical study titled "Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation". In this study, the investigators test 2 dose levels of thiotepa (5 mg/kg and 10 mg/kg) added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG) to determine the minimum effective dose required for reliable engraftment for subjects undergoing h...

What is the current status of trial NCT03513328?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2018-06-15. Estimated completion is 2023-02-19.

What interventions are being tested in trial NCT03513328?

The interventions under investigation include: Thiotepa--single daily dose (DRUG), Thiotepa--escalated dose (DRUG).

Who is sponsoring clinical trial NCT03513328?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

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

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.