CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 412 enrolled
Drug / intervention
ATGdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01883180
NCT01883180Phase 4Completed
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Dose Study of Antithymocyteglobulin in Haploidentical Hematopoietic Stem Cell Transplantation for Acute Graft-versus-host Disease Prophylaxis

Nanfang Hospital, Southern Medical University·interventional·Posted Jun 21, 2013·Updated Apr 24, 2018

In Brief

A Phase 4 clinical trial evaluating ATG for Hematopoietic Stem Cell Transplantation and 2 related conditions. Completed, enrolled 412 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the incidences of GVHD and viral infections in haploidentical hematopoietic stem cell transplant recipients receiving different dose of antithymocyte globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. Our first objective was to investigate the optimal dose of ATG for aGVHD and second object was to evaluate the effect of different dose of ATG on post-transplant viral infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematopoietic Stem Cell Transplantation, Antithymocyte Globulin, Viral Infection
CountriesChina
CollaboratorsPeking University People's Hospital, First Affiliated Hospital of Guangxi Medical University, Southern Medical University, China, Guangzhou General Hospital of Guangzhou Military Command, Fujian Medical University Union Hospital, Xiangya Hospital

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 21, 2013
Enrollment StartJun 1, 2013
Primary CompletionSep 1, 2017
Study CompletionJan 1, 2018
TodayJul 1, 2026
Enrollment to primary: 4.3 yearsPosted 13.0 years ago

Interventions

ATGdrug

ATG will be intravenously infused via a central venous catheter in 3 or 4 days, from day -4 or -3 until day -1. The other conditioning drugs administered before transplantation include cytosine arabinoside (Ara-C), busulfan (Bu),cyclophosphamide (Cy), Semustine(Me-CCNU), and ATG. All transplant recipients will receive cyclosporine A (CsA), mycophenolate mofetil(MMF), and short-term methotrexate for aGVHD prevention.