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

Trial: HOVON 115 Double UCBT


News
1. Overview
Study details
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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1. Overview



Summary

Double umbilical cord blood transplantation in high-risk hematological patients.
A phase II study focussing on the mechanism of graft predominance.


Status

open


Members

HOVON



Study details



Type of study

Prospective Phase II study


Echelon level

Level A


Type of monitoring for this study

Site evaluation visits


Target number of patients

70


Current number of patients

70


Study objectives

To study the presence of an alloreactive immune
response of CD4+ T-cells of the predominant
CBU, directed against the non-engrafting CBU as
a causative mechanism in CBU predominance.
To assess engraftment and engraftment kinetics;
to evaluate immune reconstitution, acute and
chronic GVHD, chimerism, toxicity, progression-
free survival and overall survival after double unit
UCBT.


2. Patient eligibility criteria



Inclusion criteria

• Age 18-70 years inclusive
• Diagnosis of poor-risk hematological malignancy or (V)SAA relapsing after or failing immunosuppressive therapy and meeting the criteria for a MUD allo SCT
Lacking a sufficiently matched volunteer
unrelated donor or lacking such a donor within
the required time period of ≤ 2 months in case of
urgently needed alloSCT
Availability of 2 (≥4/6) matched UCB grafts with a
total nuclear cell count > 4 x 107/kg (see
paragraph 8.2).
WHO performance status 0-2
Written informed consent


Exclusion criteria

Bilirubin and/or transaminases > 2.5 x normal value
Creatinine clearance < 40 ml/min
Cardiac dysfunction as defined by:
- Reduced left ventricular function with an
ejection fraction < 45% as measured by
MUGA scan or echocardiogram (another
method for measuring cardiac function is
acceptable)
 - Unstable angina
 - Unstable cardiac arrhythmias
Pulmonary function test with VC, FEV1 and/ or
DCO < 50%
Active, uncontrolled infection
History of high dose (≥ 8 Gy) total body irradiation
Pregnant or lactating females
HIV positivity


3. Registration (& randomization) of patients



Registration

Patients need to be registered at the HOVON Data Center of the Erasmus MC - Daniel den Hoed
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
Local patient code (optional)
Sex
Date of birth
Date written informed consent
Specific items patient gives consent for (see ICF)
Eligibility criteria


4. Participating parties



Principal Investigator(s)

Prof. Dr. J.J. Cornelissen (Erasmus MC - Daniel)


Co-Investigator(s)

Mw. J.A.E. Somers (Erasmus MC - Daniel)


Statistician(s)

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


Monitor - Site Evaluation Visits

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


Other functions

Central Coordinator - Special Investigations - Dhr. Dr. E. Braakman (Erasmus MC - Medische Faculteit)
Central Coordinator - Special Investigations - Dr. C.H.J. Lamers (Erasmus MC - Daniel)
Central Coordinator - Special Investigations - Mw. J.A.E. Somers (Erasmus MC - Daniel)
Central Coordinator - Special Investigations - Transplantatie lab (Erasmus MC - Centrum)
Central Coordinator - Special Investigations - Mw. J.M.E. van de Weerd (Sanquin Research)


5. Participating sites



Site
Included patients *
NL-Amsterdam-AMC
7
NL-Amsterdam-VUMC
8
NL-Leiden-Leids Universitair Medisch Centrum
5
NL-Nijmegen-Radboudumc
2
NL-Rotterdam-Erasmus MC - Daniel
32
NL-Utrecht-UMCU
16

* 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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