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Completed

NCT Number: NCT01883180

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

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplantation Antithymocyte Globulin Infections Viral Infection Virus Diseases

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ATG

Drug

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 outcomes

  1. Incidence of Epstein-Barr virus(EBV) viremia

    Time frame: 1 year

    Incidence of EBV viremia within 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • First Affiliated Hospital of Guangxi Medical University
  • Fujian Medical University Union Hospital
  • Guangzhou General Hospital of Guangzhou Military Command
  • Peking University People's Hospital
  • Southern Medical University, China
  • Xiangya Hospital

Registry information

Official study title

Dose Study of Antithymocyteglobulin in Haploidentical Hematopoietic Stem Cell Transplantation for Acute Graft-versus-host Disease Prophylaxis

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Jun 21, 2013
Registry last updated
Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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