This site is intended for healthcare professionals
  • Home
  • /
  • Clinical trials
  • /
  • Uncategorised Disease
  • /
  • Chronic Graft-versus-host Disease (cGvHD) Prophyla...
Clinical trial

Chronic Graft-versus-host Disease (cGvHD) Prophylaxis With or Without ATG Prior to Stem Cell Transplantation (SCT) From HLA-identical Siblings in Patients With Acute Leukemia

Read time: 1 mins
Last updated:1st Oct 2006

This multicenter, prospective phase III-study is to compare the administration of ATG FRESENIUS to the NON-administration of ATG FRESENIUS in a myeloablative conditioning regimen followed by allogeneic hematopoeitic stem cell transplantation from an HLA-identical sibling in patients with acute Leukemia. This clinical trial is to show that the administration of ATG FRESENIUS reduces the risk of chronic Graft-versus-Host disease after allogeneic stem cell transplantation from HLA-identical siblings.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prophylaxis of Chronic Graft-versus-host Disease (cGvHD) With or Without Anti-T-lymphocyte-globulin (ATG Fresenius) Prior Allogeneic Peripheral Stem Cell Transplantation From HLA-identical Siblings After Myeloablative Conditioning in Patients With Acute Leukemia: A Randomized Phase III-study
Enrollment: 161
Study Start Date: October 2006
Study Completion Date: March 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

Arms:
- A (Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, RECEIVING ATG in conditioning regimen)
- B (Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, NOT RECEIVING ATG in conditioning regimen)


Related journal: Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease.

Category Value
Study start date 2006-10-01

View full details