Extracorporeal Photopheresis in Children and Young Adults With Refractory Acute Graft Versus Host Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Purpose : to evaluate the efficacy of ECP in children with refractory acute GVHD This study addresses patients with persistent GVHD after steroid and/or monoclonal antibody therapy

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Extracorporeal Photopheresis for Acute Graft Versus Host Disease

NCT00179855

Graft Versus Host Disease Cancer Stem Cell Transplantation

COMPLETED PHASE2/PHASE3

Extracorporeal Photopheresis to Treat Chronic Graft-Versus-Host Disease

NCT00048789

Graft vs Host Disease

COMPLETED PHASE2

ECP Combination Study

NCT05052385

Steroid Refractory GVHD

COMPLETED

Extracorporeal Photopheresis Using Theraflex ECP™ for Patients With Refractory Chronic Graft Versus Host Disease (cGVHD)

NCT03083574

Refractory Chronic Graft Versus Host Disease (cGVHD)

UNKNOWN PHASE2

Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease

NCT00054613

Graft-versus-Host Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

One arm. Six sessions in two weeks. Classification in complete response (resolution of all signs of GVHD), partial response (improvement of at least one grade) or absence of response (Glucksberg criteria). Tapering depending on patient condition during weeks 2 to 10. Final evaluation at week 10. Steroid therapy tapering at the discretion of the investigator.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Graft Versus Host Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ECP (performed on Themos UVAR-XTS or external UVA irradiator after cell collection by apheresis)

ECP (performed on Thermos UVAR-XTS or external UVA irradiator after cell collection by apheresis)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 0 to 30 years
* Acute GVHD refractory to steroids (disease progression after 2 days or absence of response after 4 days) and/or second line therapy (absence of response after 8 days)
* patient consent and/or parent consent

Exclusion Criteria

* less of 10 kgs BW
* clinical or biological state precluding the apheresis
* previous GVHD therapy with anti-lymphocyte serum (excepted in the conditioning regimen)

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No