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

Chinese PLA General Hospital100 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

aGVHD

Interventions

ATGDRUG

rabbit ATG（Sanofi）

CsADRUG

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.

mycophenolate mofetilDRUG

From day -9, 0.5 g of mycophenolate mofetil was administered orally from every 12 h, which was withdrawn on day +30 for MSD-PBSCT.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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);

Locations (1)

Liping Dou

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Number of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria)

Chronic graft versus host disease grading criteria (refer to NIH criteria)

Time frame: three years

Secondary Outcomes

all cause mortality

Time frame: two years

Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria

Time frame: two years

DFS(disease-free survival )

disease-free survival

Time frame: two years

TRM(treatment-related mortality )

treatment-related mortality

Time frame: two years

Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)

Time frame: three months

Data from ClinicalTrials.gov

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