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NCT03018223 · ClinicalTrials.gov registry record · Phase 1

Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haplo PBSCT

A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT03018223 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 32 participants.

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The verdict

NCT03018223, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study Summary

The purpose of this study is to find out if a combination of drugs (these are called: cyclophosphamide, sirolimus, and mycophenolate mofetil) will protect participants better against graft vs. host disease (GVHD) after receiving a hematopoietic cell transplant from a related partially matched (haploidentical) donor. As part of the treatment for their blood cancer, participants need a hematopoietic cell transplantation (HCT) to improve their chances of cure. In any HCT, after the stem cell infusion is given, a combination of drugs is needed to prevent GVHD and facilitate acceptance of the graft.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Busulfan
  • RADIATION Total body irradiation (TBI)
  • PROCEDURE Peripheral Blood Hematopoietic Cell Transplantation (HCT)

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2017-01-31
Est. Completion 2021-03-18
Phase Phase 1

What the Registry Record Tells You About NCT03018223

The ClinicalTrials.gov registry entry for NCT03018223 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT03018223 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03018223 about?

NCT03018223 is a clinical study titled "Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haplo PBSCT". The purpose of this study is to find out if a combination of drugs (these are called: cyclophosphamide, sirolimus, and mycophenolate mofetil) will protect participants better against graft vs. host disease (GVHD) after receiving a hematopoietic cell transplant from a related partially matched (haplo...

What is the current status of trial NCT03018223?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2017-01-31. Estimated completion is 2021-03-18.

What interventions are being tested in trial NCT03018223?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Total body irradiation (TBI) (RADIATION), Peripheral Blood Hematopoietic Cell Transplantation (HCT) (PROCEDURE).

Who is sponsoring clinical trial NCT03018223?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

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.