NCT03689465

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2018

Typical duration for phase_4

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 29, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 28, 2019

Status Verified

September 1, 2019

Enrollment Period

1.9 years

First QC Date

August 13, 2018

Last Update Submit

October 24, 2019

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Hematopoietic Stem Cell Transplantationposttransplantation cyclophosphamideantithymocyte globulinviral infectiongraft-versus-host disease

Outcome Measures

Primary Outcomes (1)

  • CMV DNAemia

    CMV DNAemia was defined as positive CMV-DNA in the blood when the copies exceeded 500 copies/ml.

    1 year posttransplantation

Secondary Outcomes (6)

  • aGVHD

    100 days 1 year posttransplantation

  • cGVHD

    2 year posttransplantation

  • EBV DNAemia

    1 year posttransplantation

  • Leukemia relapse

    2 year posttransplantation

  • OS

    2 year posttransplantation

  • +1 more secondary outcomes

Study Arms (2)

PTCy-ATG group

ACTIVE COMPARATOR

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: ATGDrug: CTXDrug: Mycophenolate MofetilDrug: Ciclosporin A (CsA)

ATG group

ACTIVE COMPARATOR

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: ATGDrug: Mycophenolate MofetilDrug: Ciclosporin A (CsA)Drug: methotrexate (MTX)

Interventions

ATGDRUG

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.

ATG groupPTCy-ATG group
CTXDRUG

In PTCy-ATG group, CTX will be intravenously infused via a central venous catheter on day +4 at a dose of 50mg/kg/d.

PTCy-ATG group
Mycophenolate MofetilDRUG

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.

ATG groupPTCy-ATG group
Ciclosporin A (CsA)DRUG

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.

ATG groupPTCy-ATG group
methotrexate (MTX)DRUG

In ATG group, methotrexate (MTX) will be intravenously on days +1, +3 and +6.

ATG group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

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

Guangzhou, Guangdong, China

NOT YET RECRUITING

The Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Xiangya Hospital, Central South University

Changsha, Hunan, China

NOT YET RECRUITING

Chenzhou First People's Hospital

Chenzhou, Hunan, China

NOT YET RECRUITING

Peking University People's Hospital

Beijing, China

NOT YET RECRUITING

Related Publications (3)

  • Wang Y, Fu HX, Liu DH, Xu LP, Zhang XH, Chang YJ, Chen YH, Wang FR, Sun YQ, Tang FF, Liu KY, Huang XJ. Influence of two different doses of antithymocyte globulin in patients with standard-risk disease following haploidentical transplantation: a randomized trial. Bone Marrow Transplant. 2014 Mar;49(3):426-33. doi: 10.1038/bmt.2013.191. Epub 2013 Dec 2.

    PMID: 24292519BACKGROUND

  • Chang YJ, Huang XJ. Haploidentical SCT: the mechanisms underlying the crossing of HLA barriers. Bone Marrow Transplant. 2014 Jul;49(7):873-9. doi: 10.1038/bmt.2014.19. Epub 2014 Feb 24.

    PMID: 24566712BACKGROUND

  • Baron F, Mohty M, Blaise D, Socie G, Labopin M, Esteve J, Ciceri F, Giebel S, Gorin NC, Savani BN, Schmid C, Nagler A. Anti-thymocyte globulin as graft-versus-host disease prevention in the setting of allogeneic peripheral blood stem cell transplantation: a review from the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation. Haematologica. 2017 Feb;102(2):224-234. doi: 10.3324/haematol.2016.148510. Epub 2016 Dec 7.

    PMID: 27927772BACKGROUND

MeSH Terms

Conditions

Virus DiseasesGraft vs Host Disease

Interventions

Mycophenolic AcidCyclosporinsMethotrexate

Condition Hierarchy (Ancestors)

InfectionsImmune System Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Qifa Liu

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ren Lin, M.D.

CONTACT

+86-020-62787883lansinglinren@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 13, 2018

First Posted

September 28, 2018

Study Start

October 29, 2018

Primary Completion

September 30, 2020

Study Completion

December 31, 2020

Last Updated

October 28, 2019

Record last verified: 2019-09

Locations

CN(7)