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

Last updated: October 24, 2019
Sponsor: Nanfang Hospital of Southern Medical University
Overall Status: Active - Recruiting

Phase

4

Condition

Bone Marrow Transplant

Anemia

Treatment

N/A

Clinical Study ID

NCT03689465
PTCy-ATG-2018
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 informedconsent document indicating that they understand the purpose of and proceduresrequired for the study and are willing to participate in the study

Exclusion

Exclusion Criteria:

  • Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or bloodpressure)

  • Patients with any conditions not suitable for the trial (investigators' decision)

Study Design

Total Participants: 260
Study Start date:
October 29, 2018
Estimated Completion Date:
December 31, 2020

Study 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.

Connect with a study center

  • Department of Hematology,Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The Third Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Xiangya Hospital, Central South University

    Changsha, Hunan
    China

    Site Not Available

  • Chenzhou First People's Hospital

    Chenzhou, Hunan
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing,
    China

    Site Not Available

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