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Clinical picture: Other

Trial: HOVON 106 DOUBLE UCBT

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1. Overview
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Download documentation / forms

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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

planned

Members

HOVON

Type of study

Prospective Phase II study

Type of monitoring for this study

Site evaluation visits

Target number of patients

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

J.J Cornelissen (j.cornelissen@erasmusmc.nl)

Study coordinators

J.A.E. Somers (j.somers@erasmusmc.nl)

Statistician(s)

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

Trial manager

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

Central data management