EBMT NEWSLETTER | September 2014 | Volume 43 - Issue 1

Important dates

Resistance Pattern of Gram-negative Bacteria Isolated from Blood from HSCT Recipients.

A non-interventional prospective multicentre study by the IDWP
to determine the incidence and pattern of antimicrobials resistance
among Gram-negative bacteria isolated from blood in HSCT patients
during the first 6 months after the transplantation. 

This study is still recruiting
There is a significant increase in resistant bacteria emerging in HSCT recipients. These resistant bacteria may be associated with increased mortality and the treatment options are limited. To provide the currently best empirical coverage and to control the growing resistance, knowledge of trends in antibiotic susceptibility as well as risk factors is essential. For this reason we would like to perform a non-interventional prospective multicentre study among EBMT centres.

Within 1 year we aim to collect 365 episodes of Gram-negative bacterial infections by following 3650 transplants recipients. The background information about the transplantations will be collected via the standard MED A form. Data on all the episodes of Gram-negative bacteria blood stream infections will be collected prospectively from the initiation of the conditioning treatment until the end of the first 6 months after the HSCT (or death or lost follow-up, if they occur earlier). Data on the patients who will develop a Gram-negative infection will be reported using a special MED C form.

Study period: February 2014 – July 2015

Currently 90 centres are participating,
aiming to collect 6600 transplants
and 600 cases of gram-negative bacteremia.
Inclusion criteria
Allogeneic or autologous HSCT recipients, of all ages, for any indications.
Exclusion criteria:
Patients who are not willing to participate. 
For participating centres:

Please note that the study period has started and that you can now report your cases of gram-negative bacteremia for patients that were transplanted after the 1st of February of 2014.
For each separate case you should complete the MED C form. Please use the study manual while completing the form. For certain questions it might be difficult to derive the meaning from the questionnaire itself. The manual has been created to properly define those issues, in order to avoid inconsistency in the answers from the different participating centres.
It is advised to designate one person in your hospital responsible for tracking the episodes.
This study is still recruiting
When your centre is interested in participating in this important study, or when you have any questions or concerns,  please contact Jennifer Hoek of the EBMT Data Office via idwpebmt@lumc.nl

Prospective analysis of prognostic pre-transplant factors in myelodysplastic syndromes primarily treated by allogeneic hematopoietic stem cell transplantation: a study on behalf of the MDS subcommittee of the Chronic Malignancies Working Party of the EBMT

Call for missing data

Since February 1st, 2013 the study has been closed for new patient inclusions and we are currently awaiting follow-up information (up to 2 years).

Please, send the complete due follow-up forms of the included patients and all consecutive eligible patients before September 30th 2014. Due follow-up forms and patients can be send to: 

EBMT Data Office Leiden
Department of Medical Statistics & BioInformatics, Postzone S-05-P, LUMC,
PO Box 9600, 2300 RC Leiden, The Netherlands. 
Tel: +31 71 526 1513
Fax: +49 711 4900 8723 (fax to e-mail system)
Fax: +49 180 500 290 623 (fax to e-mail system)
E-mail:  clwpebmt@lumc.nl

Do not hesitate to contact us in case of any questions.

When complete information on all eligible patients from your centre are received, we are able to pay the fee of €500,- per patient. Upon publication participating centres will be acknowledged.

We would like to thank all the participating centres for their contribution in this important study.

The Effect of 2nd generation TKI on the outcome after allogeneic SCT for Patients with CML:

A non-Interventional Prospective Study by the CMWP

We would like to take this opportunity to thank all participants for their ongoing cooperation in this important study! 

The collection of MED B/C and follow up data is well under way. Over summer the number of completed forms has increased from ca. 50% to 70%. This is a wonderful achievement and we hope that this sets a trend for the last year in the study. Thank you!

For  study documents or information about the study, please contact Jennifer Hoek, study coordinator at the EBMT Data Office in Leiden, via j.d.c.hoek@lumc.nl
Please, do not forget to send in your patients’ MED C form!
MPN subcommittee of the CMWP

The RACE study: A prospective, Randomized  multi-centre study comparing horse Antithymocyte globulin (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients.

A multi-center project of the EBMT and SAAWP

The main aim of this study is to improve the number of patients achieving complete response (CR)  through the addition of Eltrombopag to standard treatment (hATG + CsA) and serve as front-line treatment for severe aplastic anemia patients.

Eltrombopag is a compound which stimulates the functioning of the bone marrow independently from IST. It has recently been demonstrated that eltrombopag, besides stimulating platelet production, may also be effective on the other blood cell lineages. 
During the RACE study the hypothesis that eltrombopag, added to the standard (hATG + CsA) treatment, results in an increase of the 3 months response rate up to 21% (by 3 folds) is investigated. 

Patients participating in the RACE study will by randomized to either the standard treatment arm (hATG + CsA) or to the investigational treatment arm (hATG + CsA + eltrombopag). For patients in the standard treatment arm there is an option for treatment with open-label eltrombopag (for 6 months) when they show no response to standard treatment after 12 months. Patients in the investigational arm will initially receive eltrombopag for 3 months. If they did not achieve CR they will receive eltrombopag for an additional 3 months. In case of patients who experience relapse within 6 months from eltrombopag stop, eltrombopag can be re-introduced for 6 months.

The study is currently in its start-up phase and will soon be submitted to competent authorities. RACE will have a total duration of five years (including two years of follow up).
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