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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05214066
Other study ID # 81370667
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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