The purpose of this study is to compare the incidences of GVHD and viral infections in haploidentical hematopoietic stem cell transplant recipients receiving different dose of antithymocyte globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. Our first objective was to investigate the optimal dose of ATG for aGVHD and second object was to evaluate the effect of different dose of ATG on post-transplant viral infection.
Allogeneic hematopoietic stem cell transplantation (allo-HSCT)is the only therapeutic option for many hematological malignancies. Unfortunately, about 75% of patients who require allo-HSCT lack human leukocyte antigen (HLA)-matched donors. The alternative is hematopoietic stem cells from an HLA-mismatched family donor. However, this strategy, which is called haploidentical HSCT, may be associated with high risk of early death and severe GVHD. Opportunistic infections are common complications after allo-HSCT. Due to the absence of effective preventive and therapeutic drugs for most viruses, viral infections has become one of the most important causes of death. The immunosuppression regimen including ATG has been shown effective to prevent severe GVHD in haploidentical HSCT. But this strategy delays immune reconstitution, and therefore increase the risk of viral infection. The optimal dose of the different ATG preparations with respect to prevention of GvHD is not fully understood today. The total doses between 6 mg/kg to 15 mg/kg are effective for prevention of GVHD, but the dose above 10 mg/kg may increase the development of viral infection. In this trial, we will focus on the incidence of aGVHD and viral infections in patients treated with 7.5mg/kg or 10mg/kg of ATG. The incidence of GVHD and viral infections will be compared between different dose arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
412
ATG will be intravenously infused via a central venous catheter in 3 or 4 days, from day -4 or -3 until day -1. The other conditioning drugs administered before transplantation include cytosine arabinoside (Ara-C), busulfan (Bu),cyclophosphamide (Cy), Semustine(Me-CCNU), and ATG. All transplant recipients will receive cyclosporine A (CsA), mycophenolate mofetil(MMF), and short-term methotrexate for aGVHD prevention.
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Incidence of Epstein-Barr virus(EBV) viremia
Incidence of EBV viremia within 1 year
Time frame: 1 year
Incidence of acute GVHD
Acute GVHD was graded according to standard criteria.
Time frame: 100 days
Incidence of EBV-associated diseases
the Incidence of EBV-associated end-organ diseases
Time frame: 2 years
Immune reconstitution
Immune reconstitution is performed every 3 months after transplantation.
Time frame: 1 year
Survival
Survival includes overall and disease-free survival within 2 years after transplantation.
Time frame: 3 years
Incidence of chronic GVHD
Chronic GVHD was assessed in patients alive after day 100.
Time frame: 2 years
Incidence of cytomegalovirus(CMV) viremia
Incidence of CMV viremia within 1 year
Time frame: 1 year
Incidence of CMV-associated diseases
the Incidence of CMV-associated end-organ diseases
Time frame: 2 years
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