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

October 24, 2019 updated by: Qifa Liu, Nanfang Hospital of Southern Medical University

A Comparison of PTCy-ATG and ATG Strategy in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Peking University People's Hospital
        • Contact:
          • Wang Yu
        • Sub-Investigator:
          • Xiaojun Huang
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
          • Danian Nie
        • Sub-Investigator:
          • Danian Nie
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Guangzhou First People's Hospital
        • Contact:
          • Shunqing Wang
        • Sub-Investigator:
          • Shunqing Wang
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Department of Hematology,Nanfang Hospital, Southern Medical University
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • The Third Affiliated Hospital, Sun Yat-sen University
        • Contact:
          • Dongjun Lin
        • Sub-Investigator:
          • Dongjun Lin
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Xiangya Hospital, Central South University
        • Contact:
          • yajing xu
        • Sub-Investigator:
          • Yajing Xu
      • Chenzhou, Hunan, China
        • Not yet recruiting
        • Chenzhou First People's Hospital
        • Contact:
          • Xinquan Liang
        • Sub-Investigator:
          • Xinquan Liang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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), a dose of 2.5mg/kg/d Ciclosporin A （CsA）, 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 +4 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. In ATG group, Mycophenolate Mofetil will be taken orally from day -9 with the dosage of 0.5g twice a day. The dosage will be halved from day +30.
Drug: Ciclosporin A (CsA)
In PTCy-ATG group, Ciclosporin A (CsA) will be intravenously infused from day +5 at a dose of 2.5mg/kg/d. In ATG group, Ciclosporin A (CsA) will be intravenously infused from day -9 at a dose of 2.5mg/kg/d.
Active Comparator: ATG group
ATG group refers to treatment with ATG protocol as GVHD prophylaxis at a total dose of 7.5mg/kg ATG, a dose of 2.5mg/kg/d Ciclosporin A （CsA）, a dose of 1.0g/d Mycophenolate Mofetil(MMF) and methotrexate (MTX, on days +1, +3 and +6).
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: 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. In ATG group, Mycophenolate Mofetil will be taken orally from day -9 with the dosage of 0.5g twice a day. The dosage will be halved from day +30.
Drug: Ciclosporin A (CsA)
In PTCy-ATG group, Ciclosporin A (CsA) will be intravenously infused from day +5 at a dose of 2.5mg/kg/d. In ATG group, Ciclosporin A (CsA) will be intravenously infused from day -9 at a dose of 2.5mg/kg/d.
Drug: methotrexate (MTX)
In ATG group, methotrexate (MTX) will be intravenously on days +1, +3 and +6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year posttransplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
100 days 1 year posttransplantation
cGVHD
Time Frame: 2 year posttransplantation
Chronic GVHD (cGVHD) was graded as limited or extensive.
2 year posttransplantation
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.
1 year posttransplantation
Leukemia relapse
Time Frame: 2 year posttransplantation
primary disease relapse
2 year posttransplantation
OS
Time Frame: 2 year posttransplantation
overall survival
2 year posttransplantation
DFS
Time Frame: 2 year posttransplantation
disease-free survival
2 year posttransplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2018

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

October 28, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTCy-ATG-2018

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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