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Trial record 27 of 66 for:    "Viral Infectious Disease" | "Mycophenolic acid"

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

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ClinicalTrials.gov Identifier: NCT03689465
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University

Brief Summary:
The granulocyte colony-stimulating factor (G-CSF)+antithymocyte globulin (ATG)-based protocols and posttransplantation cyclophosphamide (PTCy) protocols have been widely used for graft-versus-host disease (GVHD) prophylaxis in haploidentical related donor transplantation (haplo-HSCT). Nevertheless, severe acute GVHD remains an obstacle for haplo-HSCT. This study is aim to evaluate the efficacy of a modified protocol that includes PTCY and ATG in recipients of haplo-HSCT.

Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cell Transplantation Drug: ATG Drug: CTX Drug: Mycophenolate Mofetil Phase 4

Detailed Description:
Haploidentical related donor transplantation is now considered an important alternative to allogeneic hematopoietic stem cell transplantation (allo-HSCT). Currently, the strategies for graft-versus-host disease (GVHD) prophylaxis mainly include ex vivo and in vivo T-cell depletion (TCD) in haploidentical HSCT (haplo-HSCT). In vivo TCD modalities have become mainstream including granulocyte colony-stimulating factor (G-CSF)+antithymocyte globulin (ATG)-based protocols and posttransplantation cyclophosphamide (PTCy) protocols. The ATG strategy has been widely used. Nevertheless, severe acute GVHD remains an obstacle for haplo-HSCT. In addition, infections, especially viral infections, remain an important drawback of this strategy. This study is aim to evaluate the efficacy of a modified protocol that includes PTCY and ATG in recipients of haplo-HSCT.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Comparison of PTCy-ATG and ATG Strategy in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Active Comparator: PTCy-ATG group
PTCy-ATG group refers to treatment with PTCy-ATG protocol as GVHD prophylaxis at a total dose of 4.5mg/kg ATG, a dose of 50mg/kg/d cyclophosphamide (CTX) and a dose of 1.0g/d Mycophenolate Mofetil(MMF).
Drug: ATG
In PTCy-ATG group, ATG will be intravenously infused via a central venous catheter from day -3 until day -1 at a total dose of 4.5mg/kg. In ATG group, ATG will be intravenously infused via a central venous catheter from day -5 until day -2 at a total dose of 7.5mg/kg.

Drug: CTX
In PTCy-ATG group, CTX will be intravenously infused via a central venous catheter on day +3 at a dose of 50mg/kg/d.

Drug: Mycophenolate Mofetil
In PTCy-ATG group, Mycophenolate Mofetil will be taken orally from day +5 with the dosage of 0.5g twice a day. The dosage will be halved from day +30.

Active Comparator: ATG group
ATG group refers to treatment with ATG as GVHD prophylaxis at the total dose of 7.5mg/kg.
Drug: ATG
In PTCy-ATG group, ATG will be intravenously infused via a central venous catheter from day -3 until day -1 at a total dose of 4.5mg/kg. In ATG group, ATG will be intravenously infused via a central venous catheter from day -5 until day -2 at a total dose of 7.5mg/kg.




Primary Outcome Measures :
  1. CMV DNAemia [ Time Frame: 1 year posttransplantation ]
    CMV DNAemia was defined as positive CMV-DNA in the blood when the copies exceeded 500 copies/ml.


Secondary Outcome Measures :
  1. aGVHD [ Time Frame: 100 days 1 year posttransplantation ]
    aGVHD (acute GVHD) was defined according to the 1994 Consensus Conference on Acute GVHD Grading and graded from I to IV.

  2. cGVHD [ Time Frame: 2 year posttransplantation ]
    Chronic GVHD (cGVHD) was graded as limited or extensive.

  3. EBV DNAemia [ Time Frame: 1 year posttransplantation ]
    EBV DNAemia was defined as positive EBV-DNA in the blood when the copies exceeded 500 copies/ml.

  4. Leukemia relapse [ Time Frame: 2 year posttransplantation ]
    primary disease relapse

  5. OS [ Time Frame: 2 year posttransplantation ]
    overall survival

  6. DFS [ Time Frame: 2 year posttransplantation ]
    disease-free survival



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A patient age of 18-65 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): NCT03689465


Contacts
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Contact: Ren Lin, M.D. +86-020-62787883 lansinglinren@hotmail.com

Locations
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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   
Principal Investigator: Qifa Liu         
Guangzhou First People's Hospital Not yet recruiting
Guangzhou, Guangdong, China
Contact: Shunqing Wang         
Sub-Investigator: Shunqing Wang         
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China
Contact: Danian Nie         
Sub-Investigator: Danian Nie         
The Third Affiliated Hospital, Sun Yat-Sen University Not yet recruiting
Guangzhou, Guangdong, China
Contact: Dongjun Lin         
Sub-Investigator: Dongjun Lin         
China, Hunan
Xiangya Hospital, Central South University Not yet recruiting
Changsha, Hunan, China
Contact: Yajing Xu         
Sub-Investigator: Yajing Xu         
Chenzhou First People's Hospital Not yet recruiting
Chenzhou, Hunan, China
Contact: Xinquan Liang         
Sub-Investigator: Xinquan Liang         
China
Peking University People's Hospital Not yet recruiting
Beijing, China
Contact: Wang Yu         
Sub-Investigator: Xiaojun Huang         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
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Principal Investigator: Qifa Liu Nanfang Hospital of Southern Medical University

Publications:
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Responsible Party: Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03689465     History of Changes
Other Study ID Numbers: PTCy-ATG-2018
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Qifa Liu, Nanfang Hospital of Southern Medical University:
Hematopoietic Stem Cell Transplantation
posttransplantation cyclophosphamide
antithymocyte globulin
viral infection
graft-versus-host disease
Additional relevant MeSH terms:
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Mycophenolic Acid
Graft vs Host Disease
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors