NCT05718791

Brief Summary

The prediction of severe acute GVHD before it occurs is of high importance for ensuing clinical decisions and overall success of allogeneic SCT. The key immunologic signatures associated with clinical outcomes after different graft versus host disease prophylaxis methods or peripheral blood stem cell transplant are largely unknown.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
21mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
May 2023Dec 2027

First Submitted

Initial submission to the registry

January 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4.6 years

First QC Date

January 30, 2023

Last Update Submit

April 29, 2026

Conditions

GVHD,Acute

Outcome Measures

Primary Outcomes (1)

  • predictors of acute GVHD

    CXCL9 combined with EASIX can be used as predictors of acute GVHD

    CXCL9 combined with EASIX calculated at day 28 +/- 2 post SCT can be used as predictors of acute GVHD by day 100.

Interventions

blood sampleDIAGNOSTIC_TEST

blood sample to check CXCL9 and EASIX at day 28 post stem cell transplant

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients \>18 year old admitted for allo SCT PB for malignant disease

You may qualify if:

  • Patients \>18 year old admitted for allo SCT PB for malignant disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

shatha farhan, MD

CONTACT

3137133910sfarhan1@hfhs.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 8, 2023

Study Start

May 10, 2023

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

US(1)