NCT02543073

Brief Summary

Interstitial lung disease (ILD） is the late pulmonary complications after allogeneic hematopoietic stem cell transplantation (allo-HSCT) leading to high morbidity and mortality. At present, the treatment for ILD after allo-HSCT remains in discussion. In this study, the efficacy of mesenchymal stem cells (MSCs) combined azithromycin as well as glucocorticoid as the treatment of ILD will be evaluated in the recipients of allo-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
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

May 10, 2017

Status Verified

September 1, 2015

Enrollment Period

3.3 years

First QC Date

September 4, 2015

Last Update Submit

May 9, 2017

Conditions

Lung Diseases, InterstitialHematopoietic Stem Cell TransplantationBronchiolitis Obliterans

Outcome Measures

Primary Outcomes (1)

  • Response rate of ILD

    Response includes complete response (CR) and partial response (PR). CR is defined as resolution of all manifestations related to ILD, except for some irreversible changes. PR is defined as sustained, measurable improvement in pulmonary function tests(carbon monoxide lung diffusion capacity, forced expiratory volume, or both) or the ability to reduce corticosteroids by at least 50% or both without deterioration of pulmonary function.

    4 weeks

Secondary Outcomes (1)

  • Overall Survival

    3 year

Study Arms (2)

MSCs

EXPERIMENTAL

MSCs will be given the patients in MSCs group. Besides, azithromycin (AZM) and glucocorticoid will also be administered.

Biological: MSCsDrug: AZMDrug: Glucocorticoid

Non-MSCs

ACTIVE COMPARATOR

AZM and glucocorticoid will be given for the patients in Non-MSCs group.

Drug: AZMDrug: Glucocorticoid

Interventions

MSCsBIOLOGICAL

MSCs will be given at a median dose of 1×10\^6 cells/kg once weekly for 4 weeks as one cycle treatment.

MSCs
AZMDRUG

AZM will be given （0.25g qd）for 4 weeks as one cycle treatment.

MSCsNon-MSCs
GlucocorticoidDRUG

Glucocorticoid (prednison) will be given at the starting dose of 1mg/kg for 4 weeks as one cycle treatment.

MSCsNon-MSCs

Eligibility Criteria

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

You may qualify if:

  • Receiving allo-HSCT
  • Diagnosed with ILD after allo-HSCT

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 (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (2)

  • Olivieri A, Locatelli F, Zecca M, Sanna A, Cimminiello M, Raimondi R, Gini G, Mordini N, Balduzzi A, Leoni P, Gabrielli A, Bacigalupo A. Imatinib for refractory chronic graft-versus-host disease with fibrotic features. Blood. 2009 Jul 16;114(3):709-18. doi: 10.1182/blood-2009-02-204156. Epub 2009 Apr 29.

    PMID: 19403889BACKGROUND

  • Chen S, Zhao K, Lin R, Wang S, Fan Z, Huang F, Chen X, Nie D, Du X, Guo Z, Lin D, Xuan L, Xu N, Sun J, Peng Xiang A, Liu Q. The efficacy of mesenchymal stem cells in bronchiolitis obliterans syndrome after allogeneic HSCT: A multicenter prospective cohort study. EBioMedicine. 2019 Nov;49:213-222. doi: 10.1016/j.ebiom.2019.09.039. Epub 2019 Oct 23.

    PMID: 31668569DERIVED

MeSH Terms

Conditions

Lung Diseases, InterstitialBronchiolitis Obliterans

Interventions

Glucocorticoids

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesBronchiolitisBronchitisBronchial DiseasesLung Diseases, Obstructive

Intervention Hierarchy (Ancestors)

Adrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Qifa Liu, MD

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ren Lin

CONTACT

lansinglinren@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 7, 2015

Study Start

September 1, 2014

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

May 10, 2017

Record last verified: 2015-09

Locations

CN(1)