ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis
ATG Used in Allogeneic Hematopoietic Stem Cell Transplantation From HLA-matched Sibling Donor as GVHD Prophylaxis
1 other identifier
interventional
266
1 country
1
Brief Summary
The protocols including ciclosporin A （CsA）+methotrexate (MTX) +mycophenolate Mofetil(MMF) have been widely used for graft-versus-host disease (GVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from HLA-matched sibling donor (MSD). Nevertheless, severe chronic graft-versus-host disease (cGVHD) remains an obstacle for MSD HSCT. A growing body of studies have suggested antithymocyte globulin (ATG) could reduce the incidence of cGVHD. This study is aim to evaluate the efficacy of a protocol that includes CsA, MTX, MMF and ATG in recipients of MSD HSCT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2019
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
December 16, 2019
CompletedFirst Posted
Study publicly available on registry
December 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedDecember 18, 2019
December 1, 2019
2 years
December 16, 2019
December 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the incidence of cGVHD
cGVHD was graded as limited or extensive.
2 year posttransplantation
Secondary Outcomes (3)
overall survival
2 year posttransplantation
disease-free survival
2 year posttransplantation
the incidence of aGVHD
100 days 1 year posttransplantation
Study Arms (2)
ATG group
EXPERIMENTALATG group refers to treatment with a protocol including low-dose ATG, CsA, short-term MTX and MMF as GVHD prophylaxis.
non-ATG group
ACTIVE COMPARATORNon-ATG group refers to treatment with a protocol including CsA, short-term MTX and MMF as GVHD prophylaxis.
Interventions
In ATG group, ATG will be intravenously infused via a central venous catheter in day -1 at a dose of 2.5mg/kg.
In both groups, CsA will be intravenously infused from day -9 and the dose was adjusted based on the concentration.
In both groups, MTX will be intravenously on days +1(15mg), +3(10mg) and +6(10mg).
Eligibility Criteria
You may qualify if:
- A patient age of 18-65 years
- MSD transplant recipient
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
You may not qualify if:
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- Patients with any conditions not suitable for the trial (investigators' decision)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qifa Liu
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 16, 2019
First Posted
December 18, 2019
Study Start
September 1, 2019
Primary Completion
August 31, 2021
Study Completion
December 31, 2022
Last Updated
December 18, 2019
Record last verified: 2019-12