Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

412

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Jun 2013

Longer than P75 for phase_4

Geographic Reach

1 country

1 active site

Status

completed

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

4.6 years study duration

Study Start

First participant enrolled

June 1, 2013

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2013

Completed

7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed

4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed

Last Updated

April 24, 2018

Status Verified

January 1, 2018

Enrollment Period

4.3 years

First QC Date

June 14, 2013

Last Update Submit

April 21, 2018

Conditions

Hematopoietic Stem Cell Transplantation Antithymocyte Globulin Viral Infection

Keywords

haploidentical hematopoietic Stem Cell TransplantationAntithymocyte globulinviral infection

Outcome Measures

Primary Outcomes (1)

Incidence of Epstein-Barr virus(EBV) viremia
Incidence of EBV viremia within 1 year
1 year

Secondary Outcomes (7)

Incidence of acute GVHD
100 days
Incidence of EBV-associated diseases
2 years
Immune reconstitution
1 year
Survival
3 years
Incidence of chronic GVHD
2 years
+2 more secondary outcomes

Study Arms (2)

ATG 7.5mg/kg

EXPERIMENTAL

ATG 7.5mg/kg group refers to treatment with ATG in the total dose of 7.5mg/kg.

Drug: ATG

ATG 10mg/kg

EXPERIMENTAL

ATG 10mg/kg group refers to treatment with ATG in the total dose of 10mg/kg.

Drug: ATG

Interventions

ATGDRUG

ATG will be intravenously infused via a central venous catheter in 3 or 4 days, from day -4 or -3 until day -1. 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.

ATG 10mg/kgATG 7.5mg/kg

Eligibility Criteria

Age14 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

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

Nanfang Hospital, Southern Medical Universitylead
Peking University People's Hospitalcollaborator
First Affiliated Hospital of Guangxi Medical Universitycollaborator
Southern Medical University, Chinacollaborator
Guangzhou General Hospital of Guangzhou Military Commandcollaborator
Fujian Medical University Union Hospitalcollaborator
Xiangya Hospitalcollaborator

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (6)

Ottinger HD, Ferencik S, Beelen DW, Lindemann M, Peceny R, Elmaagacli AH, Husing J, Grosse-Wilde H. Hematopoietic stem cell transplantation: contrasting the outcome of transplantations from HLA-identical siblings, partially HLA-mismatched related donors, and HLA-matched unrelated donors. Blood. 2003 Aug 1;102(3):1131-7. doi: 10.1182/blood-2002-09-2866. Epub 2003 Apr 10.
PMID: 12689945BACKGROUND
Bacigalupo A, Lamparelli T, Bruzzi P, Guidi S, Alessandrino PE, di Bartolomeo P, Oneto R, Bruno B, Barbanti M, Sacchi N, Van Lint MT, Bosi A. Antithymocyte globulin for graft-versus-host disease prophylaxis in transplants from unrelated donors: 2 randomized studies from Gruppo Italiano Trapianti Midollo Osseo (GITMO). Blood. 2001 Nov 15;98(10):2942-7. doi: 10.1182/blood.v98.10.2942.
PMID: 11698275BACKGROUND
Chakupurakal G, Freudenberger P, Skoetz N, Ahr H, Theurich S. Polyclonal anti-thymocyte globulins for the prophylaxis of graft-versus-host disease after allogeneic stem cell or bone marrow transplantation in adults. Cochrane Database Syst Rev. 2023 Jun 21;6(6):CD009159. doi: 10.1002/14651858.CD009159.pub3.
PMID: 37341189DERIVED
Fan M, Wang Y, Lin R, Lin T, Huang F, Fan Z, Xu Y, Yang T, Xu N, Shi P, Nie D, Lin D, Jiang Z, Wang S, Sun J, Huang X, Liu Q, Xuan L. Haploidentical transplantation has a superior graft-versus-leukemia effect than HLA-matched sibling transplantation for Ph- high-risk B-cell acute lymphoblastic leukemia. Chin Med J (Engl). 2022 Apr 20;135(8):930-939. doi: 10.1097/CM9.0000000000001852.
PMID: 35467818DERIVED
Yu S, Huang F, Fan Z, Xuan L, Nie D, Xu Y, Yang T, Wang S, Jiang Z, Xu N, Lin R, Ye J, Lin D, Sun J, Huang X, Wang Y, Liu Q. Haploidentical versus HLA-matched sibling transplantation for refractory acute leukemia undergoing sequential intensified conditioning followed by DLI: an analysis from two prospective data. J Hematol Oncol. 2020 Mar 12;13(1):18. doi: 10.1186/s13045-020-00859-5.
PMID: 32164760DERIVED
Lin R, Wang Y, Huang F, Fan Z, Zhang S, Yang T, Xu Y, Xu N, Xuan L, Ye J, Sun J, Huang X, Liu Q. Two dose levels of rabbit antithymocyte globulin as graft-versus-host disease prophylaxis in haploidentical stem cell transplantation: a multicenter randomized study. BMC Med. 2019 Aug 12;17(1):156. doi: 10.1186/s12916-019-1393-7.
PMID: 31401973DERIVED

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

Qifa Liu, MD
Nanfang Hospital, Southern Medical University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: the director of Department of Hematology, Nanfang Hospital and vice director of Institute of Hematology, Southern Medical University.

Study Record Dates

First Submitted

June 14, 2013

First Posted

June 21, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2017

Study Completion

January 1, 2018

Last Updated

April 24, 2018

Record last verified: 2018-01

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

ATG 7.5mg/kg

ATG 10mg/kg

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations