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

Trial: HOVON 106 DOUBLE UCBT


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


HO106 news

 This study has been closed for further inclusion on 20 januari 2012

1. Overview



Summary

A phase II study to assess engraftment and engraftment kinetics after double cord blood transplantation with a reduced-intensity conditioning regimen in patients eligible for allogeneic stem cell transplantation lacking a matched unrelated donor.


Status

closed


Members

HOVON



Type of study

Prospective Phase II study


Type of monitoring for this study

Study specific


Target number of patients

40


Current number of patients

41


Date closed

20-Jan-2012


Approved by

EudraCTnr.: 2008-000053-35


Study objectives

To assess engraftment and engraftment kinetics after double cord blood transplantation preceded by a reduced-intensity conditioning regimen in patients eligible for allogeneic stem cell transplantation lacking a matched unrelated donor.
To evaluate immune reconstitution, acute and chronic GVHD, chimerism, toxicity, time to treatment failure, progression-free survival and overall survival after double unit UCBT.
To study patient-versus-graft, graft-versus-patient and graft-versus-graft interactions


2. Patient eligibility criteria



Inclusion criteria

Age 18-65 years inclusive
Meeting the criteria for a MUD allo SCT and high risk disease
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 sufficiently matched UCB grafts with a total nuclear cell count > 4 x 107/kg
WHO performance status ≤ 2
Written informed consent

High risk disease as defined by:
AML with -5, -7, EV1-expression or complex karyotype in first CR
Relapsed AML/ MDS in second or subsequent CR
ALL with t(9;22), t(4;11), t(1;19) or with high WBC at diagnosis (B-ALL > 30x109/l, T-ALL > 100x109/l) in first CR, or no CR after first induction but in CR after rescue chemotherapy
Relapsed ALL in second or subsequent CR
CML in second chronic phase after treatment for CML blast crisis
VSAA or SAA relapsing after or failing immunosuppressive therapy

Patients with the following diseases may be included if considered high risk disease:
Relapse AML with t(8;21) or inv16 in second or subsequent CR, with poor risk according to Breems prognostic score (appendix A)
AML/MDS in patients 61-65 years inclusive, in first CR
CML in second chronic phase after treatment for acceleration phase
Lymphocytoplasmacytoid lymphoma, responsive disease after at least third line chemotherapy
Folliculair NHL, responsive disease after at least third line chemotherapy
CLL, responsive disease after at least third line chemotherapy


Exclusion criteria

Relapse APL
Primary myelofibrosis
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 total body irradiation
HIV positivity


3. Registration (& randomization) of patients



Registration

Patients need to be registered and randomized 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
Patient's initials or code
Sex
Date of birth
Date written informed consent


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)


Trial manager

M.E. Groenendijk-Sijnke (m.groenendijk-sijnke@erasmusmc.nl)


5. Participating sites



Site
Included patients *
NL-Amsterdam-AMC
3
NL-Amsterdam-VUMC
2
NL-Leiden-Leids Universitair Medisch Centrum
4
NL-Maastricht-AZ Maastricht
3
NL-Rotterdam-Erasmus MC - Daniel
23
NL-Utrecht-UMCU
6

* 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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