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ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis

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ClinicalTrials.gov Identifier: NCT01883180
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
Peking University People's Hospital
First Affiliated Hospital of Guangxi Medical University
Southern Medical University, China
Guangzhou General Hospital of Guangzhou Military Command
Information provided by (Responsible Party):
Nanfang Hospital of 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.

Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cell Transplantation Antithymocyte Globulin Viral Infection Drug: ATG Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Study of Antithymocyteglobulin in Haploidentical Hematopoietic Stem Cell Transplantation for Acute Graft-versus-host Disease Prophylaxis
Study Start Date : June 2013
Primary Completion Date : September 2017
Study Completion Date : January 2018


Arm Intervention/treatment
Experimental: ATG 7.5mg/kg
ATG 7.5mg/kg group refers to treatment with ATG in the total dose of 7.5mg/kg.
Drug: ATG
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.
Experimental: ATG 10mg/kg
ATG 10mg/kg group refers to treatment with ATG in the total dose of 10mg/kg.
Drug: ATG
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.



Primary Outcome Measures :
  1. Incidence of Epstein-Barr virus(EBV) viremia [ Time Frame: 1 year ]
    Incidence of EBV viremia within 1 year


Secondary Outcome Measures :
  1. Incidence of acute GVHD [ Time Frame: 100 days ]
    Acute GVHD was graded according to standard criteria.

  2. Incidence of EBV-associated diseases [ Time Frame: 2 years ]
    the Incidence of EBV-associated end-organ diseases

  3. Immune reconstitution [ Time Frame: 1 year ]
    Immune reconstitution is performed every 3 months after transplantation.

  4. Survival [ Time Frame: 3 years ]
    Survival includes overall and disease-free survival within 2 years after transplantation.

  5. Incidence of chronic GVHD [ Time Frame: 2 years ]
    Chronic GVHD was assessed in patients alive after day 100.

  6. Incidence of cytomegalovirus(CMV) viremia [ Time Frame: 1 year ]
    Incidence of CMV viremia within 1 year

  7. Incidence of CMV-associated diseases [ Time Frame: 2 years ]
    the Incidence of CMV-associated end-organ diseases



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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883180


Locations
China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Peking University People's Hospital
First Affiliated Hospital of Guangxi Medical University
Southern Medical University, China
Guangzhou General Hospital of Guangzhou Military Command
Investigators
Principal Investigator: Qifa Liu, MD Nanfang Hospital of Southern Medical University