aGVHD, cGVHD
Conditions
Keywords
ATG, Matched sibling donor, peripheral blood stem cell transplantation
Brief 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).
Detailed 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.
Interventions
DRUGRabbit 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.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with severe cGVHD | 1 year | Chronic graft versus host disease grading criteria (refer to NIH criteria) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria) | 100 days | Cumulative incidence of aGVHD |
| OS | 1 year | overall survival of enrolled patients |
| Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria | 1 year | cumulative incidence of relapse |
| DFS | 1 year | disease-free survival |
| NRM | 1 year | non-relapse mortality |
Countries
China
Contacts
Primary ContactDaihong Liu, Doctor
Backup ContactLiping Dou, Doctor
Outcome results
None listed