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

Trial: HOVON 112 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


HO112 news

01JUN2017: Study is temporarily on hold for inclusion of new patients. More details will follow.

18MAY2015: Amendment 02 implemented in NL

27MAY2014: Study is open for inclusion in NL

 

New documents

18MAY2015: The following documents are updated in relation to AM02 approval:

- CA and EC approvals

- Protocol (clean and tracked changes version + summary of changes)

- ICFs (clean and tracked changes)

28JAN2015: GVHD scoring form for physician can be downloaded

 


1. Overview



Summary

Treatment of severe acute GVHD after allogeneic hematopoietic stem cell transplantation with steroids versus MSC and steroids. A prospective double-blind placebo-controlled randomized phase III trial.


Status

open


Members

HOVON and participating sites from United Kingdom, Spain, Germany



Type of study

Prospective double-blind randomized phase III study


Echelon level

Level A


Type of monitoring for this study

Site evaluation visits


Target number of patients

200


Current number of patients

39


Study objectives

To improve the response rate to treatment of grade II-IV acute GVHD involving gut and/or liver by adding MSC to standard high dose prednisolone
To study the safety of the addition of MSC to standard treatment of severe acute GVHD as compared to standard treatment alone
To study quality of life
To study cost-effectiveness
To study the (immunological) phenotype before and after application of MSC/placebo of responders and non-responders in both groups at different sites
To study the immunological genotype of responders and non-responders as well as donors in both groups
To study the incidence of relapse of the underlying disease (e.g. hematological malignancy)
To study progression free survival (of the underlying disease)
To study overall survival


2. Patient eligibility criteria



Inclusion criteria

Any age;
Previously treated with allo-SCT/ DLI;
Grade II-IV acute GVHD involving gut and/or liver according to appendix A (confirmed by histology of involved tissues, however, the first infusion of MSC/placebo can be given without final histological confirmation);
WHO performance 0-3;
Negative pregnancy test (if applicable);
Patients must be willing and capable to use adequate contraception during therapy (if applicable) ;
Written Informed Consent by the patient and/or parent(s) or legal guardian(s).


Exclusion criteria

Patients with active, uncontrolled infection;
Rapid progressive hematological malignancy;
Patients pre-treated with prednisolone > 1 mg/kg for GVHD, for more than 72 hours prior to randomization/application of MSC/placebo;
Known uncontrolled toxicity for DMSO;
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)
Any psychological, familial, sociological and/or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.


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
Grade acute GVHD at date of registration


4. Participating parties



Principal Investigator(s)

Prof.Dr. J.H.E. Kuball (UMCU)


Co-Investigator(s)

Dr. J.J. Boelens (UMCU)


Statistician(s)

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


Monitor - Site Evaluation Visits

Mw. W.M Keller (Erasmus MC - Daniel)
MonitorTeamCTC (Erasmus MC - Daniel)


Coordinating investigator(s)

M. Wölfl (Germany)
A. Zabalza (Spain)
R. Wynn (United Kingdom)


5. Participating sites



Site
Included patients *
NL-Amsterdam-VUMC
0
NL-Utrecht-UMCU
39

* 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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