Efficacy and Safety Study of ATG for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02677181

Enrollment

100

Registered

2016-02-09

Start date

2016-01-31

Completion date

2022-04-30

Last updated

2022-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aGVHD

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 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

DRUGATG

rabbit ATG（Sanofi）

DRUGCsA

cyclosporine (3 mg/kg, q12h, i.v.) was used from day -9, and the concentration was adjusted to 180-200 ng/mL. CsA was switched to oral administration when the patient's bowel function recovered.

DRUGmycophenolate mofetil

From day -9, 0.5 g of mycophenolate mofetil was administered orally from every 12 h, which was withdrawn on day +30 for MSD-PBSCT.

DRUGMethotrexate

short-term methotrexate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. acute myeloid leukemia (AML) in CR1 (complete remission 1) or CR2 (complete remission 2) phase regardless of cytogenetics; 2. CML CP(chronic myelogenous leukemia , chronic phase); NHL (non-Hodgkin's lymphoma ) 3. MDS-RAEB(myelodysplastic syndrome -refractory anemia with excess blasts ). 4. All patients should aged 40 to 70 years 5. Have matched sibling donor. 6. Patients without any uncontrolled infections or without severe pulmonary, renal, hepatic or cardiac diseases .

Exclusion criteria

1. Patients aged less than 40 years old ; 2. Patients with any uncontrolled infections or with severe pulmonary, renal, hepatic or cardiac diseases; 3. AML patients with t (15;17);

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria)	three years	Chronic graft versus host disease grading criteria (refer to NIH criteria)

Secondary

Measure	Time frame	Description
all cause mortality	two years	—
Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria	two years	—
DFS(disease-free survival )	two years	disease-free survival
TRM(treatment-related mortality )	two years	treatment-related mortality
Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)	three months	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026