Treatment of severe steroid-refractory acute GvHD with mesenchymal stromal cells.

Phase 1

• Conditions: Graft Versus Host Disease; MedDRA version: 18.0Level: PTClassification code 10066260Term: Acute graft versus host diseaseSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; MedDRA version: 18.0Level: LLTClassification code 10068908Term: AGVHDSystem Organ Class: 10021428 - Immune system disorders

• Registration Number: EUCTR2012-004915-30-ES
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-11
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

* Grade II-IV acute GvHD with gut and/or liver involvement, confirmed by histology of involved tissues (in case of gut and liver involvement histology of either one of these tissues is considered sufficient); N.B. if the patient is otherwise eligible but histological confirmation at randomization is lacking, the principal investigator should be contacted.*
* Non-responsive to consecutive systemic treatment with steroids at a dose of 2 mg/kg and a calcineurin-inhibitor at therapeutic trough levels, defined as:
- progressive disease or mixed response after 5-6 days of treatment.
- stage 4 GvHD of gut and/or liver after 5-6 days treatment and:
· significant deterioration of clinical parameters (gut) OR
· increase of serum total bilirubin levels in umol/L (liver)
(not attributable to other causes than acute GvHD)
- progressive disease after initial partial response of maximal 1 grade after 5-7 days of treatment
- stable disease after 7 days of treatment
See appendix A for response criteria
* Any age
* Lansky / Karnofsky score of =20;
* Signed informed consent by the patient and/or parent(s) or legal guardian(s).
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

* In Spain only adult patients will be included
* Use of prophylactic MMF or Myfortic ? 6 days prior to development of acute GvHD ;
* Systemic treatment for acute GvHD other than steroids and a calcineurin inhibitor (budesonide is considered a local treatment);
* Pre-treatment with steroids ? 1 mg/kg for more than 3 days prior to initiation of steroids at a dose of 2 mg/kg for the treatment of acute GvHD;
* Previous treatment with advanced therapy medicinal products (ATMP) potentially interfering with the endpoints of this study; N.B. if the patient has previously been treated with ATMP , the principal investigator should always be contacted prior to registration*.
* Progressive or relapsing malignant disease in case of NHL, HL, CLL, MM, and = 5% blasts in the bone marrow in case of AML, ALL, CML;
* Requiring ventilator or vasopressor support;
* Poor performance not expected to survive 14 days;
* Known seropositivity of HIV, Hepatitis B and C, HTLV;
* Known uncontrolled toxicity for DMSO;
* Known anaphylactic reaction to penicillin or streptomycin;
* Known pregnancy;
* Any psychological, familial, sociological and /or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified