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

Trial: HOVON 96 GVHD


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


HO96 news

Per 1 October 2013 protocol amendment of 17 july2013 is active. Introduced is a short-course GVHD prophylaxis consisting of post-transplant cyclophosphamide.
The inclusion in the Quality of Life investigation of the HOVON 96 GVHD study has been closed for entry of new patients. It is closed, because it has reached its target of 200 patients.
The patients already participating in Quality of life will continue in filling in Quality of Life Questionaires according to protocol.
 
Inclusion in the HOVON 96 GVHD study is going to be continued till 500 patients as stated in protocol.
 

 

 


1. Overview



Summary

Prevention of severe GVHD after allogeneic hematopoietic stem cell transplantation, applied as consolidation immunotherapy in patients with hematological malignancies. A prospective randomized phase III trial


Status

open


Members

HOVON



Type of study

Prospective randomized Phase III study


Type of monitoring for this study

Site evaluation visits


Target number of patients

500


Current number of patients

466


Date of activation

12-Apr-2010


Approved by

EudraCTnr.: 2008-003540-11
CKS: 2008-4331, 03-DEC-2008
CKS: 2009-4590 (QoL), 25-MRT-2010
NL: MEC 2009-354, 24-FEB-2010
BE: EC 01-JUN-2010


Study objectives

Objectives randomization:
to reduce the proportion of patients without GVHD within 180 days post-allo-SCT,
to reduce the progression rate and
to improve the progression free survival
to asses the impact on the quality of life using a time restricted immunosuppressive regimen as compared to a prolonged, standard immunosuppressive regimen, or using a post-transplant regimen with high-dose cyclophosphamide

Additional objective:
to develop a predictive score, by means of clinical and laboratory parameters (using genomic and proteomic approaches) that allows for accurate identification of patients at high risk of severe GVHD as well as for identification of patients, who will not develop GVHD


2. Patient eligibility criteria



Inclusion criteria

Age 18-70 inclusive
AML, MDS, ALL, MM, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD)
Planned allogeneic stem cell transplantation
Related or unrelated donor with a 8/8 HLA match (HLA A, B, C, DRB1)
WHO performance status 0-2
Written Informed Consent
Negative pregnancy test (if applicable)
Patients who are willing and capable to use adequate contraception during Myfortic treatment (all pre-menopausal women)


Exclusion criteria

Renal dysfunction (serum creatinine > 150 μmol/L or clearance < 50 ml/min)
Patients with active, uncontrolled infection
Cord Blood transplantation
Patients receiving ATG pre-transplantation as part of the conditioning regimen
Patients with progressive disease in case of MM, CLL, NHL, HL
Patients with > 5% marrow blasts in case of AML, ALL, CML
Patients with EMD in case of AML, ALL, CML


3. Registration (& randomization) of patients



Registration

Patients need to be registered and randomized at the HOVON Data Center of the Erasmus MC Cancer Institute - via the internet via Trial Online Process http://www.hdc.hovon.nl/top
or by phone call (+31.10.7041560) (working days 9.00-17.00)
or by fax (+31.10.7041028) (working days 9.00- 17.00)


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller / responsible investigator
Sex
Date of birth
Date written informed consent

Participation in the quality of life assessment is closed for new patients

Eligibility criteria (see 8.1)


4. Participating parties



Principal Investigator(s)

Mw. Dr. A.E.C. Broers (Erasmus MC - Daniel)
Mw. Dr. E. Meijer (VUMC)


Co-Investigator(s)

Prof. Dr. J.J. Cornelissen (Erasmus MC - Daniel)
Dhr. Dr. J.J.W.M. Janssen (VUMC)
Mw. Dr. E. Meijer (VUMC)


Coordinating Investigator(s)

Prof. dr. J.A. Maertens (UZ Gasthuisberg)


Statistician(s)

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


Monitor - Site Evaluation Visits

Mw. S. Jägers (Erasmus MC - Daniel)
Mw. W.M Keller (Erasmus MC - Daniel)
Mw. L. Sitniakowsky (Erasmus MC - Daniel)
Dhr. T. Volker (Erasmus MC - Daniel)


Other functions

Central Coordinator - QoL - Mw. A.C.J. Ammerlaan (Erasmus MC - Daniel)


Statistician(s)

B. van der Holt (b.vanderholt@erasmusmc.nl)


Trial manager

I. Meulendijks (L.Meulendijks@erasmusmc.nl)


Central data management

I. Meulendijks (L.Meulendijks@erasmusmc.nl)
M. Abrahamse - Testroote (m.testroote@erasmusmc.nl)
R. Sewsaran (r.sewsaran@erasmusmc.nl)


5. Participating sites



Site
Included patients *
BE-Leuven-UZ Gasthuisberg
2
BE-Roeselare-AZDelta
1
NL-Amsterdam-AMC
58
NL-Amsterdam-VUMC
75
NL-Groningen-UMCG
29
NL-Maastricht-AZ Maastricht
4
NL-Rotterdam-Erasmus MC - Daniel
260
NL-Utrecht-UMCU
1
NL-Zwolle-Isala
36

* 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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