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α1-antitrypsin (AAT) Levels and Functions in Allogeneic Bone Marrow Transplantation and Throughout Progression Into GVHD

NCT03188601 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 27

Last updated 2023-04-04

No results posted yet for this study

Summary

Create a personalized time and context curve of patient circulating α1-antitrypsin (AAT) levels and functions before hematopoietic stem cell transplantation and throughout progression into GVHD.

PRIMARY ENDPOINT 1. Serum AAT levels and activity, before myeloablative preconditioning, as well as on days (-3),0,7,14,28 from HSCT and every 21 days thereafter.

SECONDARY ENDPOINTS 1. Correlation between AAT patterns and:

* Circulating immune cell activation profiles on day of ablation, 28 days from HSCT and once GVHD is diagnosed.
* Patient survival
* Liver function tests
* GVHD grade: skin manifestations, weight, GI and liver histopathology
* Graft-versus-leukemia effect

Conditions

  • GVHD
  • Bone Marrow Transplant Failure
  • Alpha 1-Antitrypsin

Sponsors & Collaborators

  • Soroka University Medical Center

    collaborator OTHER

  • Tel-Aviv Sourasky Medical Center

    collaborator OTHER_GOV

  • Hadassah Medical Organization

    collaborator OTHER

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Eli Lewis, Professor · Ben-Gurion University of the Negev

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-27
Primary Completion
2022-02-01
Completion
2022-08-01

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03188601 on ClinicalTrials.gov