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

This study is currently recruiting participants.
Verified September 2015 by Nanfang Hospital of Southern Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01883180
First Posted: June 21, 2013
Last Update Posted: May 16, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
  Purpose
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 Intervention Phase
Hematopoietic Stem Cell Transplantation Antithymocyte Globulin Viral Infection Drug: ATG Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • Incidence of Epstein-Barr virus(EBV)and cytomegalovirus(CMV) infections [ Time Frame: 1 years ]
    EBV and CMV infections include EBV and CMV viremia, and associated diseases


Secondary Outcome Measures:
  • Incidence of acute GVHD [ Time Frame: 2 years ]
    Acute GVHD was graded according to standard criteria.

  • 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.

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


Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 0. 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 0. 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.

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.

  Eligibility

Information from the National Library of Medicine

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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)
  Contacts and Locations
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


Contacts
Contact: Ren Lin, MD +86-020-61641613 lansinglinren@hotmail.com

Locations
China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Ren Lin, MD    +86-020-61641613    lansinglinren@hotmail.com   
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
  More Information

Publications:
Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01883180     History of Changes
Other Study ID Numbers: NFEC-201304-K1
First Submitted: June 14, 2013
First Posted: June 21, 2013
Last Update Posted: May 16, 2017
Last Verified: September 2015

Keywords provided by Nanfang Hospital of Southern Medical University:
haploidentical hematopoietic Stem Cell Transplantation
Antithymocyte globulin
viral infection

Additional relevant MeSH terms:
Graft vs Host Disease
Virus Diseases
Immune System Diseases