Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01883180
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : April 24, 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
Fujian Medical University Union Hospital
Xiangya Hospital
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University

Tracking Information
First Submitted Date  ICMJE June 14, 2013
First Posted Date  ICMJE June 21, 2013
Last Update Posted Date April 24, 2018
Study Start Date  ICMJE June 2013
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2018)
Incidence of Epstein-Barr virus(EBV) viremia [ Time Frame: 1 year ]
Incidence of EBV viremia within 1 year
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
Incidence of Epstein-Barr virus(EBV)and cytomegalovirus(CMV) infections [ Time Frame: 2 years ]
The primary endpoint includes EBV and CMV infections within 2 years after transplantation. EBV and CMV infections include EBV and CMV viremia, and associated diseases.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2018)
  • Incidence of acute GVHD [ Time Frame: 100 days ]
    Acute GVHD was graded according to standard criteria.
  • Incidence of EBV-associated diseases [ Time Frame: 2 years ]
    the Incidence of EBV-associated end-organ diseases
  • Immune reconstitution [ Time Frame: 1 year ]
    Immune reconstitution is performed every 3 months after transplantation.
  • Survival [ Time Frame: 3 years ]
    Survival includes overall and disease-free survival within 2 years after transplantation.
  • Incidence of chronic GVHD [ Time Frame: 2 years ]
    Chronic GVHD was assessed in patients alive after day 100.
  • Incidence of cytomegalovirus(CMV) viremia [ Time Frame: 1 year ]
    Incidence of CMV viremia within 1 year
  • Incidence of CMV-associated diseases [ Time Frame: 2 years ]
    the Incidence of CMV-associated end-organ diseases
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
  • GVHD [ Time Frame: 2 years ]
    GVHD includes acute GVHD and chronic GVHD.
  • Drug-related adverse events of ATG [ Time Frame: 2 years ]
    Drug-related adverse events include acute toxicity and late side effects.
  • Immune reconstitution [ Time Frame: 2 years ]
    Immune reconstitution is performed every 3 months after transplantation.
  • Survival [ Time Frame: 2 years ]
    Survival includes overall and disease-free survival within 2 years after transplantation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis
Official Title  ICMJE Dose Study of Antithymocyteglobulin in Haploidentical Hematopoietic Stem Cell Transplantation for Acute Graft-versus-host Disease Prophylaxis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hematopoietic Stem Cell Transplantation
  • Antithymocyte Globulin
  • Viral Infection
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: ATG 7.5mg/kg
    ATG 7.5mg/kg group refers to treatment with ATG in the total dose of 7.5mg/kg.
    Intervention: Drug: ATG
  • Experimental: ATG 10mg/kg
    ATG 10mg/kg group refers to treatment with ATG in the total dose of 10mg/kg.
    Intervention: Drug: ATG
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2018)
412
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2013)
100
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01883180
Other Study ID Numbers  ICMJE NFEC-201304-K1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qifa Liu, Nanfang Hospital of Southern Medical University
Study Sponsor  ICMJE Nanfang Hospital of Southern Medical University
Collaborators  ICMJE
  • Peking University People's Hospital
  • First Affiliated Hospital of Guangxi Medical University
  • Southern Medical University, China
  • Guangzhou General Hospital of Guangzhou Military Command
  • Fujian Medical University Union Hospital
  • Xiangya Hospital
Investigators  ICMJE
Principal Investigator: Qifa Liu, MD Nanfang Hospital of Southern Medical University
PRS Account Nanfang Hospital of Southern Medical University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP