Efficacy and Safety Study of 4-Day ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT

aGVHD Clinical Trial

Official title:

Prospective Study of Combined 4-Day ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05214066
• Other study ID #: 81370667
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2019
• Est. completion date: August 1, 2022

Study information

• Verified date: January 2022
• Source: Chinese PLA General Hospital
• Contact: Daihong Liu, Doctor
• Phone: +8613681171597
• Email: daihongrm[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of combined ATG #antithymocyte globulin # regimen (5mg/kg divided from day -5 to day -2) for aGVHD(acute graft-versus-host disease ) prophylaxis in matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT).

Description:

Transplantation with G-CSF #Granulocyte colony stimulating factor #mobilized peripheral blood stem cell (PBSCT) has been a stable transplant setting with matched sibling donor transplantation. Unmanipulated haploidentical donor PBSCT (haplo-PBSCT) has been applied in patients with hematologic malignancies. In our previous cohort study, haplo-PBSCT was associated with lower incidence of severe acute GVHD and extensive chronic GVHD compared with matched sibling donor PBSCT (MSD-PBSCT). Haplo-PBSCT has the same GVHD prophylaxis regimen with MSD-PBSCT, except ATG. It suggested the potential advantage of ATG in prophylaxis of GVHD and improvement of long term quality of life of the transplant recipients, which motivate us to observe the efficacy of combined ATG regimen for GVHD prophylaxis in MSD-PBSCT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients were aged from 14 to 65 years;
• Patients were diagnosed of acute leukemia or MDS;
• There were indications of MSD-PBSCT for these patients;
• Patients without any uncontrolled infections or without severe pulmonary, renal, hepatic or cardiac diseases.

Exclusion Criteria:

• Patients with any uncontrolled infections or with severe pulmonary,renal, hepatic or cardiac diseases;
• AML patients with t (15;17).

Related Conditions & MeSH terms

• aGVHD
• cGVHD

Intervention

Drug:
• Rabbit ATG
ATG (Thymoglobuline, rabbit) was used as 1 mg/kg/d from day -5 to day -3 and 2 mg/kg/d on day -2.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with severe cGVHD	Chronic graft versus host disease grading criteria (refer to NIH criteria)	1 year
Secondary	Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)	Cumulative incidence of aGVHD	100 days
Secondary	OS	overall survival of enrolled patients	1 year
Secondary	Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria	cumulative incidence of relapse	1 year
Secondary	DFS	disease-free survival	1 year
Secondary	NRM	non-relapse mortality	1 year