Preventing the bone marrow graft from attacking the host's organs by injection of regulatory cells.

Donor Regulatory T cells (Treg) infusion (DTI) in patients with steroid-refractory chronic graft-versus-host disease (GVHD).

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000301-71-BE

Enrollment

Registered

2012-12-06

Start date

2013-01-25

Completion date

Unknown

Last updated

2014-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Steroid-refractory chronic graft-versus-host-disease. MedDRA version: 16.1 Level: PT Classification code 10066261 Term: Chronic graft versus host disease System Organ Class: 10021428 - Immune system disorders

Interventions

Product Name: regulatory T cells Product Code: Treg Pharmaceutical Form: Infusion Trade Name: Rapamune Pharmaceutical Form: Tablet INN or Proposed INN: SIROLIMUS CAS Number: 53123-88-9 Other descript

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Signed informed consent. •Grafts from HLA-identical siblings or HLA-matched unrelated donor (1 of 10 HLA-mismatch is allowed). •= 18 years of age. •Steroid-refractory or steroid-resistant chronic GVHD defined as: -development of 1 or more new sites of disease while being treated for chronic GVHD, -progression of existing sites of disease while receiving treatment for chronic GVHD, -failure to improve despite at least 1 month of standard treatment for chronic GVHD. •Severe chronic GVHD and contra-indication to the use of steroids. •GFR > 25 mL/min. •No alemtuzumab administration in the last 6 years. •Karnofsky performance score = 70%. •DLCO > 35% and no need of supplemental continuous oxygen. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17

Exclusion criteria

Exclusion criteria: •Prior failure of rapamycine as treatment for chronic GVHD •Contra-indication to the use of rapamycin. •HIV seropositivity. •Fungal infection with radiological progression after treatment •Other uncontrolled infection. •Progression of the hematological malignancy. •Active post-transplant microangiopathy or previous microangiopathy while on rapamycine. •Uncontrolled hypertriglyceridemia

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the clinical and immunological impact of donor Treg infusion (DTI) in patients with steroid-refractory chronic GVHD ;Secondary Objective: ;Primary end point(s): To assess the safety of a combination of donor Treg infusion and rapamycine administration in patients with steroid-refractory chronic GVHD. ;Timepoint(s) of evaluation of this end point: Monitoring throughout the whole trial	—

Measure

Time frame

Main Objective: To evaluate the clinical and immunological impact of donor Treg infusion (DTI) in patients with steroid-refractory chronic GVHD ;Secondary Objective: ;Primary end point(s): To assess the safety of a combination of donor Treg infusion and rapamycine administration in patients with steroid-refractory chronic GVHD. ;Timepoint(s) of evaluation of this end point: Monitoring throughout the whole trial

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Secondary

Measure	Time frame
Secondary end point(s): 1.To assess the efficiency of Treg selection with the Clinimacs procedure. 2.To assess the response rate of chronic GVHD (defined using the NIH criteria) to donor Treg infusion + rapamycine. 3.To compare response rate of chronic GVHD in patients given Treg infusion + rapamycine (DTI arm) versus in those given rapamycine without Treg infusion (control arm; vide infra). 4.To compare the incidence of viral, bacterial, fungal and parasitic infection in patients given Treg infusion + rapa (DTI arm) versus in those given rapa without Treg infusion (control arm; vide infra). 5.To compare overall survival, progression-free survival and relapse incidence in patients given Treg infusion + rapamycine (DTI arm) versus in those given rapa without Treg infusion (control arm; vide infra). 6.To assess the impact of 3-4 weeks rapamycine administration on percentage and absolute counts of Treg and conventional T cells. 7.To compare immunological changes in patients given Treg infusion + rapamycine (DTI arm) versus in those given rapamycine without Treg infusion (control arm; vide infra). ;Timepoint(s) of evaluation of this end point: 1-The day after that of the donor's blood sampling. 2-at 1, 2, 3, 6 and 12 mths after rapamycine. 3-The day of inclusion (1ts day of rapamycine). •3 to 4 wk after rapamycine (but before DTI). •4-5 wk after rapamycine (control arm). •3 wk after DTI (DTI arm) or 6-7 wk after rapamycine onset (control arm). •3, 6 and 12 mth after rapamycine. 4-Monitoring throughout the whole trial 5-Monitoring throughout the whole trial 6-Between week 3 and 4 after rapamycine. 7-The day of inclusion (or the first day of rapamycine). •3 to 4 wk after rapamycine (but before DTI). •1 week after DTI (DTI arm) or 4-5 wk after rapamycine (control arm). •3 wk after DTI (DTI arm) or 6-7 wk after rapamycine (control arm). •3, 6 and 12 mth after rapamycine.	—

Measure

Time frame

Secondary end point(s): 1.To assess the efficiency of Treg selection with the Clinimacs procedure. 2.To assess the response rate of chronic GVHD (defined using the NIH criteria) to donor Treg infusion + rapamycine. 3.To compare response rate of chronic GVHD in patients given Treg infusion + rapamycine (DTI arm) versus in those given rapamycine without Treg infusion (control arm; vide infra). 4.To compare the incidence of viral, bacterial, fungal and parasitic infection in patients given Treg infusion + rapa (DTI arm) versus in those given rapa without Treg infusion (control arm; vide infra). 5.To compare overall survival, progression-free survival and relapse incidence in patients given Treg infusion + rapamycine (DTI arm) versus in those given rapa without Treg infusion (control arm; vide infra). 6.To assess the impact of 3-4 weeks rapamycine administration on percentage and absolute counts of Treg and conventional T cells. 7.To compare immunological changes in patients given Treg infusion + rapamycine (DTI arm) versus in those given rapamycine without Treg infusion (control arm; vide infra). ;Timepoint(s) of evaluation of this end point: 1-The day after that of the donor's blood sampling. 2-at 1, 2, 3, 6 and 12 mths after rapamycine. 3-The day of inclusion (1ts day of rapamycine). •3 to 4 wk after rapamycine (but before DTI). •4-5 wk after rapamycine (control arm). •3 wk after DTI (DTI arm) or 6-7 wk after rapamycine onset (control arm). •3, 6 and 12 mth after rapamycine. 4-Monitoring throughout the whole trial 5-Monitoring throughout the whole trial 6-Between week 3 and 4 after rapamycine. 7-The day of inclusion (or the first day of rapamycine). •3 to 4 wk after rapamycine (but before DTI). •1 week after DTI (DTI arm) or 4-5 wk after rapamycine (control arm). •3 wk after DTI (DTI arm) or 6-7 wk after rapamycine (control arm). •3, 6 and 12 mth after rapamycine.

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Countries

Belgium

Contacts

Public ContactFrédéric Baron

CHU-ULg

F.Baron@ulg.ac.be32043667201

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026