CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 418 enrolled
Drug / intervention
ATG/PTCy +2 moredrug
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/NCT03608059
NCT03608059Phase 4Completed
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Shanghai General Hospital Affiliated to Shanghai Jiao Tong University

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine·interventional·Posted Jul 31, 2018·Updated Oct 5, 2023

In Brief

A Phase 4 clinical trial evaluating ATG/PTCy, standard ATG, and 1 other intervention for Myeloid Tumor. Completed, enrolled 418 participants across 6 sites.

Detailed Summary

A novel regimen, which is composed of a low dose of ATG (5 mg/kg) and low-dose PTCy (one dose of PTCy, 50mg/kg) for GvHD prophylaxis in Haplo-PBSCT for patients with hematologic malignancies, was designed to decrease the risk of aGvHD and lower the incidence of virus reactivation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyeloid Tumor
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJul 31, 2018
Enrollment StartJul 28, 2018
Primary CompletionAug 23, 2023
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 7.9 years ago

Interventions

ATG/PTCydrug

low dose Antithymocyte Globulin plus low dose post-transplant cyclophosphamide as graft-versus-host disease prophylaxis in haploidentical peripheral blood stem cell transplantation

standard ATGdrug

in vivo T cell depletion (TCD) with anti-thymocyte globulin (ATG) as graft-versus-host disease prophylaxis in haploidentical peripheral blood stem cell transplantation

standard PTCydrug

post-transplant cyclophosphamide (PTCy) as graft-versus-host disease prophylaxis in haploidentical peripheral blood stem cell