EBMT NEWSLETTER | November 2014 | Volume 44 - Issue 2

EBMT
Important dates

The CALM study

Collaboration to Collect Autologous transplant outcomes in Lymphoma and Myeloma patients 

Call for data 

First we would like to thank you all for sending in your data and for the hard work you have done! Of the 9500 transplants we are collecting in total, 8000 MED-B and 6600 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.  
Please send in your remaining MED B, AUTOgraft and MED C data as soon as possible.
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.

In order to spread the workload, we would like to ask you to send us data on an on-going base.
 
MED C data collection
The amount of MED C forms received is not yet equal to the amount of MED B forms. Many MED C forms are still missing. Please note that in order for us to reimburse you we have to receive both forms per patient, MED B and MED C. For MM patients you should also complete a separate MED C form for the 2nd and 3rd transplantation.
 
Data submission deadline
The data submission deadline of September 30 has passed. Individual cases for deadline extension will be reviewed by the data office.
 
Data quality Excel files
The last few months we have received many data quality files for the baseline MED B and MED C items. We are currently processing these files. By the end of the year a final quality check regarding the baseline data will be performed. If the level of missing data is still insufficient an updated version of the data quality file will be sent to you.
Please note that the follow up quality checks in 2015 will be handled in the same way as the base line quality checks.
 
CALM study coordination
Any CALM study related correspondence/questions can be send to Paul Bosman or Steffie van der Werf  via e-mail address: calmebmt@lumc.nl.

Association between Uric Acid Levels and Graft-versus-Host Disease.

A non-interventional prospective study by the CQLWP.

This study is still recruiting

Danger signals are increasingly recognized to play a role during the pathology of graft-versus-host disease (GVHD). Uric acid acts as a danger signal and is released from injured cells during conditioning for allogeneic hematopoietic stem cell transplantation (allo-SCT). Recently, it has been demonstrated in preclinical models that uric acid contributes to GVHD. In a small pilot trial in the Massachusetts General Hospital, the depletion of uric acid with Raspuricase prior to allo-SCT led to a reduced incidence of GVHD (ASH 2012 Abstract 3063, Brunner et al.).

We are conducting a prospective study to assess uric acid levels of patients undergoing allo-SCT and correlate them to clinical outcome. The study will contribute to a better understanding of the role of danger signals during inflammatory diseases such as GVHD. The results may be used as clinical rationale for a prospectively randomized trial on depletion of uric acid for GVHD prophylaxis.
 
Study period: July 01, 2014 – June 30, 2015
Currently 30 centres are participating aiming to collect 400 patients
 
Study Population:
  • First allo-SCT from HLA-matched sibling donors given stem cell grafts (bone marrow or peripheral blood) without T cell depletion.
  • Patients with acute leukemia, MDS or lymphoma
  • Myeloablative or dose-reduced/non-myeloablative conditioning
Data collection:
  • MED B/C form
  • Uric Acid measurements prior and as close to day 0 of allo-SCT as possible

This study is still recruiting.

If you would like to participate or need more information regarding this study, please contact Steffie van der Werf of the EBMT Data Office in Leiden via LEWPebmt@lumc.nl

Incidence and outcome of pregnancy following stem cell transplantation.

A retrospective study by the CQWP

This study is still recruiting

It is more than 10 years since we last collected data on pregnancy after stem cell transplantation. We wish to repeat the study in order to i) increase the number of pregnancies evaluated, ii) gain information from reduced intensity conditioning protocols, and iii) to gain information on the outcome of artificial reproductive methods.

We are therefore performing a retrospective study on the incidence and outcome of pregnancies involving all men and women reported to EBMT who have undergone an allogeneic and/or autologous SCT and survived a minimum of 2 months.

Study start: September 01, 2014
Currently 110 centres have agreed to participate aiming to collect over 600 pregnancies

Inclusion criteria
  • Patient has undergone an autologous and/or allogeneic SCT between 1994 and 2014 
  • Female patient who has carried children in her own uterus
  • Male patient who has used his own sperm to father a child
Data collection

Please note that the study period has started and that you can now report your data. 
For each identified patient you should complete a restricted MED B form and a brief Med C.
 
Please send in your data!
 
When your centre is interested in participating in this important study, or when you have any questions or concerns,  please contact Steffie van der Werf of the EBMT Data Office via lewpebmt@lumc.nl
 
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