ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis
- Conditions
- Hematopoietic Stem Cell TransplantationAntithymocyte GlobulinViral Infection
- Interventions
- Registration Number
- NCT01883180
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 412
- A patient age of 14-65 years
- Haploidentical hematopoietic stem cell transplant recipient
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- Patients with any conditions not suitable for the trial (investigators' decision)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ATG 10mg/kg ATG ATG 10mg/kg group refers to treatment with ATG in the total dose of 10mg/kg. ATG 7.5mg/kg ATG ATG 7.5mg/kg group refers to treatment with ATG in the total dose of 7.5mg/kg.
- Primary Outcome Measures
Name Time Method Incidence of Epstein-Barr virus(EBV) viremia 1 year Incidence of EBV viremia within 1 year
- Secondary Outcome Measures
Name Time Method Incidence of acute GVHD 100 days Acute GVHD was graded according to standard criteria.
Incidence of EBV-associated diseases 2 years the Incidence of EBV-associated end-organ diseases
Incidence of cytomegalovirus(CMV) viremia 1 year Incidence of CMV viremia within 1 year
Immune reconstitution 1 year Immune reconstitution is performed every 3 months after transplantation.
Incidence of chronic GVHD 2 years Chronic GVHD was assessed in patients alive after day 100.
Incidence of CMV-associated diseases 2 years the Incidence of CMV-associated end-organ diseases
Survival 3 years Survival includes overall and disease-free survival within 2 years after transplantation.
Trial Locations
- Locations (1)
Department of Hematology,Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China