NCT02241018

Brief Summary

The purpose of this study is to compare the efficacy of CD25 monoclonal antibody and calcineurin inhibitors with or without mesenchymal stem cells (MSCs) in treating patients with steroid-resistant acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation.

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
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2014

Typical duration for phase_2

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
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

4 years

First QC Date

September 13, 2014

Last Update Submit

September 13, 2014

Conditions

Acute Graft-versus-host Disease

Keywords

Hematopoietic Stem Cell TransplantationMesenchymal Stem CellsCD25 Monoclonal AntibodyAcute Graft-versus-host disease

Outcome Measures

Primary Outcomes (1)

  • The efficacy of treatment for steroid-resistant aGVHD

    The responses to aGVHD are according to the literature criteria, including completely response (CR), partial response (PR) and no response (NR), and CR is defined as resolution of all symptoms of aGVHD; PR is defined as a decrease by at least 1 GVHD stage in any 1 organ system without deterioration in others 24. Overall response (OR) includes CR and PR.

    1 year

Secondary Outcomes (3)

  • Incidence of infections

    1 year

  • Incidence of primary underlying disease relapse

    1 year

  • Incidence of chronic GVHD

    1 year

Study Arms (2)

Mesenchymal stem cells

EXPERIMENTAL

MSCs will be given at a median dose of 1Ă—10\^6 cells/kg once weekly for 4 dose (as 1 cycle) or until CR. The response should be evaluated at 3 and 4 weeks. If symptoms of aGVHD progress at 3 weeks or the patients have NR at 4 weeks, these patients will switch to other therapy. If patients achieved PR at 4 weeks, another cycle will be given. Besides, CD25 monoclonal antibody (20mg/kg) will be administered at day 1,4,8,15, 21 and calcineurin inhibitors will also be used.

Drug: CD25 monoclonal antibodyDrug: calcineurin inhibitorsBiological: MSCs

CD25 Mc Ab & calcineurin inhibitors

EXPERIMENTAL

CD25 monoclonal antibody (20mg/kg, day 1,4,8,15,21) will be administered combined with calcineurin inhibitors. The response should be evaluated at 3 and 4 weeks. If symptoms of aGVHD progress at 3 weeks or the patients have NR at 4 weeks, these patients will switch to other therapy. If patients achieved PR at 4 weeks, another cycle will be given.

Drug: CD25 monoclonal antibodyDrug: calcineurin inhibitors

Interventions

CD25 monoclonal antibodyDRUG
CD25 Mc Ab & calcineurin inhibitorsMesenchymal stem cells
calcineurin inhibitorsDRUG
CD25 Mc Ab & calcineurin inhibitorsMesenchymal stem cells
MSCsBIOLOGICAL
Mesenchymal stem cells

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age of 14-65 years
  • steroid-resistant aGVHD
  • subjects (or their legally acceptable representatives) must have signed an informed consent document

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 (4)

  • Le Blanc K, Rasmusson I, Sundberg B, Gotherstrom C, Hassan M, Uzunel M, Ringden O. Treatment of severe acute graft-versus-host disease with third party haploidentical mesenchymal stem cells. Lancet. 2004 May 1;363(9419):1439-41. doi: 10.1016/S0140-6736(04)16104-7.

    PMID: 15121408BACKGROUND

  • Perez-Simon JA, Lopez-Villar O, Andreu EJ, Rifon J, Muntion S, Diez Campelo M, Sanchez-Guijo FM, Martinez C, Valcarcel D, Canizo CD. Mesenchymal stem cells expanded in vitro with human serum for the treatment of acute and chronic graft-versus-host disease: results of a phase I/II clinical trial. Haematologica. 2011 Jul;96(7):1072-6. doi: 10.3324/haematol.2010.038356. Epub 2011 Mar 10.

    PMID: 21393326BACKGROUND

  • Zhao K, Lin R, Fan Z, Li Z, Chen X, Xuan L, Huang F, Xu N, Wu X, Chen S, Sun J, Zhang X, Weng J, Li Y, Li Y, Lin D, Nie D, Wang S, Xu X, Zhang X, Li Y, Xiang AP, Wang Y, Liu Q. Reduced morbidity and mortality of cGVHD in patients who received treatment with mesenchymal stromal cells for steroid-resistant aGVHD: long-term follow-up of a randomized phase 3 trial. Exp Hematol Oncol. 2025 Jul 9;14(1):95. doi: 10.1186/s40164-025-00687-8.

    PMID: 40635107DERIVED

  • Zhao K, Lin R, Fan Z, Chen X, Wang Y, Huang F, Xu N, Zhang X, Zhang X, Xuan L, Wang S, Lin D, Deng L, Nie D, Weng J, Li Y, Zhang X, Li Y, Xiang AP, Liu Q. Mesenchymal stromal cells plus basiliximab, calcineurin inhibitor as treatment of steroid-resistant acute graft-versus-host disease: a multicenter, randomized, phase 3, open-label trial. J Hematol Oncol. 2022 Mar 7;15(1):22. doi: 10.1186/s13045-022-01240-4.

    PMID: 35255929DERIVED

MeSH Terms

Interventions

PC61 monoclonal antibodyCalcineurin Inhibitors

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Qifa Liu, MD

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ren Lin

CONTACT

+86-020-62787883lansinglinren@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2014

First Posted

September 16, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations

CN(1)