EBMT NEWSLETTER | July 2014 | Volume 42 - Issue 3

EBMT
Important dates

The CALM study

Collaboration to Collect Autologous transplant outcomes in Lymphoma and Myeloma patients
 

Call for data!!

 
We would like to thank all of those who sent in their data and for the hard work done! Almost all CALM centres are up and running and we have received a lot of data these last few months. Of the 9500 transplants we are collecting in total, 7400 MED-B and 6100 MED-C forms have been received. We are well on our way but still need more data in order to reach our target of 9500 transplants.
 
Therefore, we would still like to urge you to please send in your MED B (including Follow Up) and MED C data as soon as possible, if you haven’t already done so.  
If you are not performing your own data entry, you can send the MED-B data for the prospective transplantations (not yet registered in ProMISe) to the EBMT Data Office in London.
 
The MED-B data for retrospective transplantations (already registered in ProMISe) as well as the MED-C data for all transplantations should be sent to the EBMT Data Office in Leiden. Please note that for Multiple Myeloma for the consecutive 2nd and 3rd transplants a separate MED C form should be completed as well!  
If you are performing your own data entry, please be reminded to create a working party record in ProMISe and enter the CALM study code 42206644. If you have already entered your patients in Promise please let us know and we can assign the CALM study code for you.  
In order to spread the workload, we would like to ask you to send us data on an on-going base.
 
Extension data submission deadline:
The deadline for MED B/C data submission has been extended until September 15, 2014.             
Data quality Excel files
The last months data quality files have been sent out to ask for the baseline MED B and MED C and Follow Up items  that are missing. Please return these files before September 30, 2014.  
CALM study coordination
Any CALM study related correspondence/questions can be sent to Steffie van der Werf, Paul Bosman or Cora Knol via e-mail address: calmebmt@lumc.nl.

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

A Non-Interventional Prospective Study by the CMWP

 

Call for data

 
Almost all patients have been registered in the EBMT database, only a few patients are left to register. Please check whether all your patients included in the TKI study are also registered in ProMISe (the EBMT database).
 
The submission of MED B/C and follow up data for this study can be improved. Therefore we want to ask all participants to update their patients in the study at their earliest convenience.

Data for this study includes: study specific MED B form + Day100 form, short MED C form, yearly follow up form.

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!
 
We would like to thank all participants for their ongoing cooperation in this important study!
 
CML subcommittee of the CMWP
 


 

Non-interventional Prospective Study on the Role of Donor vs Recipient NK Cell Allo-reactivity in Haploidentical Hematopoietic Transplantation for Hematological Malignancies

*** this study is open for recruitment***

The Immunobiology Working Party (IWP) is conducting a study to evaluate the role of donor vs recipient NK cell allo-reactivity in haploidentical hematopoietic transplantation for hematologic malignancies. Donor-versus-recipient NK cell allo-reactivity is a key therapeutic element in the success of HLA haplotype mismatched (“haploidentical”) hematopoietic stem cell transplants for acute myeloid leukemia. The role of NK cell allo-reactivity will be assessed separately in T cell depleted and T cell replete transplants in the following two patient populations:
  1. AML or ALL in any remission;
  2. AML or ALL in chemo-resistant relapse.
These summer reminders will be sent to the centres that agreed to participate, but did not send any data yet. Please see the leaflet for more information on recruitment for this study.
 

Pre-Transplant Prognostic Factors in Patients with untreated MDS and CMML undergoing Allogeneic Stem Cell Transplantation. (Iron Toxicity study).

 

A non-interventional prospective study by the CMWP.

 
The MDS subcommittee of the Chronic Malignancies Working Party (MDS-CMWP) is conducting a non-interventional prospective study on pre-transplant prognostic factors including transfusion dependency and iron toxicity in adult patients with MDS and CMML, undergoing an allogeneic stem cell transplantation.
 
We would like to thank all the participating centres for their contribution in this important study.
 

Call for missing data

 

Since February 1st, 2013 the study has been closed for new patient inclusions and we are collecting currently follow-up information (up to 2 years). Please, check if you have sent in all your eligible patients and please, send us the complete follow-up forms in time so this study can be closed in time. All due data needs to be sent to the Data Office Leiden before September 30th 2014. After this date we will start the analysis for the abstract of the EBMT. Of course with reference to the centres participating in this study. During the summer you will be contacted about the missing data of your centre.

In case of any questions please contact the EBMT Data Office in Leiden, The Netherlands via clwpebmt@lumc.nl


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 01FEB2014.
 
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 .
 

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