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Clinical picture: SCT (Stem Cell Transplantation and Cellular Therapies)

Trial: HOVON 113 MSC


News
1. Overview
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


New SAE form

An incorrect fax number was listed on the SAE form of the HOVON 113 MSC study.

The SAE form has been adapted and uploaded on the website.

Please discard any old versions you may have on your site and download the new version from this website.


1. Overview



Summary

Treatment of severe steroid-refractory acute GvHD with mesenchymal stromal cells.
A phase III randomized double-blind multi-center HOVON study.


Status

open


Members

HOVON and participating sites from Italy, Sweden, Germany, Spain



Type of study

Prospective double-blind randomized phase III study


Echelon level

Level A
Level B


Type of monitoring for this study

Site evaluation visits


Target number of patients

150


Current number of patients

18


Date of activation

09-Dec-2013


Approved by

EudraCTnr.: 2012-004915-30
EC CCMO: NL42497.000.12


Study objectives

Primary objective
To improve the response rate to treatment of acute GvHD grade II-IV (with gut and/or liver involvement) by early addition of MSC to standardized second line treatment

Secondary objectives
To study the safety of MSC addition to second line treatment
To assess the overall survival
To assess the progression-free survival
To reduce the time required for continued pharmacological immune suppression
To assess the incidence of severe bacterial, viral and fungal infections
To assess the incidence and severity of chronic GvHD
To evaluate the quality of life of patients treated with MSC in comparison with controls up to two years after MSC treatment
To develop a score by means of clinical and laboratory parameters that allows for identification of patients with acute GvHD that will respond to MSC treatment


2. Patient eligibility criteria



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:
o progressive disease or mixed response after 5-6 days of treatment.
o 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
o progressive disease after initial partial response of maximal 1 grade after 5-7 days of treatment
o 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).


Exclusion criteria

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.
* Discussions with the principal investigator regarding the eligibility of a patient should always be recorded in the source documentation.


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
ErasmusMC - Clinical Trial Center
Postbus 2040
3000 CA Rotterdam
Phone number: +31.10.7041560 (working days 9.00 - 17.00)
Fax number: +31.10.7041028
TOP address: https://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller/responsible investigator
Local patient code (optional)
Sex
Date of birth
Date written informed consent
Specific items patient gives consent for (see ICF)
Eligibility criteria
Stratification factors
Availability of investigational product


4. Participating parties



Principal Investigator(s)

Prof. Dr. W.E. Fibbe (Leids Universitair Medisch Centrum)


Co-Investigator(s)

Mw. L.E.M. Oosten (Leids Universitair Medisch Centrum)
Dhr. Dr. J.J. Zwaginga (Leids Universitair Medisch Centrum)


Coordinating Investigator(s)

K. Le Blanc (Karolinska UH loc. Huddinge)
Dr. F. Locatelli (Ospedale Pediatrico Bambino Gesù)
Dr. D. Niederwieser (University of Leipzig)
F. Sanchez-Guijo (University Hospital of Salamanca)
Prof. Dr. T. de Vos (UZ Gasthuisberg)


Statistician(s)

Dhr. Dr. B. van der Holt (Erasmus MC - Daniel)


Monitor - Site Evaluation Visits

Mw. S. Jägers (Erasmus MC - Daniel)


Monitor - Study Specific

Dhr. S. Bergheanu (InterEuropa Clinical Research BV)
Mw. C. Lardinois (InterEuropa Clinical Research BV)


Central data management

Charlotte Pires (charlotte.pires@intereuropa.org)


5. Participating sites



Site
Included patients *
BE-Leuven-UZ Gasthuisberg
0
DE-Leipzig-University of Leipzig
4
ES-Salamanca-University Hospital of Salamanca
1
NL-Amsterdam-AMC
1
NL-Leiden-Leids Universitair Medisch Centrum
11
NL-Rotterdam-Erasmus MC - Daniel
1

* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms


 Protocol



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