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NCT02678143 · ClinicalTrials.gov registry record · Phase 1

Nonmyeloablative Conditioning for Mismatched Hematopoietic Stem Cell Transplantation for Severe Sickle Cell Disease

A Phase 1 study, sponsored by Washington University School of Medicine.

Terminated
Registry status
Phase 1
Development phase
1
Enrollment target

NCT02678143 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 1 participants.

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The verdict

NCT02678143, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.

TERMINATED
Registry status
Phase 1
Development phase
1 participants
Enrollment target

Study Summary

The aim of this study is to evaluate the overall safety and feasibility of using haploidentical or one antigen mismatch unrelated hematopoietic stem cell transplant (HSCT) for adult patients with severe sickle cell disease (SCD) who undergo a non-myeloablative preparative regimen consisting of total body irradiation (TBI), cyclophosphamide and alemtuzumab (and fludarabine for haplo-SCT only) and graft vs. host disease (GvHD) prophylaxis consisting of post-transplant cyclophosphamide (PT-Cy), mycophenolate mofetil (MMF), and sirolimus. The investigators anticipate that this approach will expand the donor pool and offer a safe and less toxic curative intervention.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Sirolimus
  • DRUG Alemtuzumab
  • DRUG Mycophenolate mofetil

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2016-04-26
Est. Completion 2021-11-16
Phase Phase 1

What the Registry Record Tells You About NCT02678143

The ClinicalTrials.gov registry entry for NCT02678143 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

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

NCT02678143 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02678143 about?

NCT02678143 is a clinical study titled "Nonmyeloablative Conditioning for Mismatched Hematopoietic Stem Cell Transplantation for Severe Sickle Cell Disease". The aim of this study is to evaluate the overall safety and feasibility of using haploidentical or one antigen mismatch unrelated hematopoietic stem cell transplant (HSCT) for adult patients with severe sickle cell disease (SCD) who undergo a non-myeloablative preparative regimen consisting of total...

What is the current status of trial NCT02678143?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2016-04-26. Estimated completion is 2021-11-16.

What interventions are being tested in trial NCT02678143?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Sirolimus (DRUG), Alemtuzumab (DRUG), Mycophenolate mofetil (DRUG).

Who is sponsoring clinical trial NCT02678143?

This trial is sponsored by Washington University School of Medicine, which has 1,502 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.