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Donor Regulatory T Cells Infusion in Patients With Chronic Graft-versus-host Disease (GVHD)

NCT01903473 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-09-22

No results posted yet for this study

Summary

The immune system has offensive and defensive capacities. In bone marrow transplantation, offensive cells in the donor grafts may attack host's organs, leading to a complication known as Graft versus Host Disease (GVDH). At present, patients receive steroid treatment to combat this tricky situation. Nevertheless, some patients do not respond to this therapy. Recently, it has been shown that immune system cells having defensive capacities can help in preventing the occurrence of a GVDH.

This study aims to evaluate if these protective cells together with a non-standard immunosuppressor can improve the clinical condition and suppress the activity of the offensive cells in the graft.

Conditions

  • Chronic Graft-Versus-Host Disease
  • Acute Graft-Versus-Host Disease
  • Steroid Refractory Graft-Versus-Host Disease

Interventions

DRUG

Rapamycin

Rapamycin will be started within 2 weeks after inclusion. Rapamycin will be given at 2-6 mg loading dose for one day, followed by approximately 1 mg daily to achieve a target trough level of 5 to 10 ng/mL. The frequency of trough level measurements will be done according to the investigator choice; Rapamycin may be discontinued in case of resolution of chronic GVHD ≥ 3 months or in case of un-manageable side effects or progression of chronic GVHD. Calcineurin inhibitor discontinuation within 2 weeks after rapamycin initiation. No other modification of immunosuppressive drugs and in particular no decrease in the dose of steroids (unless necessary for side effects).

OTHER

T regulatory cells

One infusion of ≥ 0.5 x10E6 T reg cells/kg recipient at 60-90 days after first day of rapamycin administration and after calcineurin inhibitor discontinuation. The infusion procedure will take one hour. Low-dose Il-2 (1x106 IU/day) will be started the day of DTI and will be continued for a period of 2months in order to expand infused donor Tregs.

Sponsors & Collaborators

  • University of Liege

    lead OTHER

Principal Investigators

  • Frédéric Baron, MD, PhD · CHU-ULg

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2022-09-12
Completion
2022-09-12

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01903473 on ClinicalTrials.gov