EBMT NEWSLETTER | September 2015 | Volume 48 - Issue 3

EBMT
Important dates

Invitation for participation: MDS and MPN (myelofibrosis) Data Quality Initiatives and Liver Toxicity study

We would like to invite you to participate in retrospective studies designed to improve the Data Quality of the EBMT registry for MDS and for MPN.
 
The Data Quality Initiative (DQI) studies will focus on the impact of the pre-graft treatment on the response of the post-graft outcome. To do these studies, essential data should be updated: i.e. pre-treatment, cytogenetics,  comorbidities, GvHD prophylaxis, as well as follow up information.
 
These Data Quality Initiatives (DQIs) aim to include more patients with complete data. Besides above study, future studies would also benefit from these DQIs.
 
We would also like to invite you to participate in a retrospective study called “Prevalence of liver toxicity in the early post-transplant period in patients with myelofibrosis”. For this study a possible patient fee is available.
The aim of the liver toxicity study is to analyze post-transplant liver toxicity in patients with Myelofibrosis.
 
To participate with the MDS DQI, please fill in the following survey https://www.surveymonkey.com/r/KP36S8W
 
To participate with the MPN DQI and Liver Toxicity, please fill in the following survey
https://www.surveymonkey.com/r/BMKBMYS

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)1. 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 GVHD2. 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.). Retrospective data from clinical studies is contradictory: GVHD was associated to low uric acid levels prior to allo-SCT in two independent cohorts (EBMT 2015 Abstract 551)3. On the other hand, different investigators found that high uric acid levels were associated to increased GVHD severity (EBMT 2015 Abstract 548) and to increased incidence of VOD (EBMT 2015 Abstract 605). Taken together there is strong evidence that danger signals, such as uric acid, may impact allo-SCT outcome.
 
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:  Start July 01, 2014
We are aiming to collect 400 patients. Currently 75 patients are included.
 
Study Population:
  • First allo-SCT from HLA-matched sibling donors given stem cell grafts (bone marrow or peripheral blood).
  • 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
 
Participating centers, please include your patients  
 
If you would like to participate or need more information regarding this study, please contact Steffie van der Werf from the EBMT Data Office in Leiden via CQWPebmt@lumc.nl   

1. Zeiser R, Penack O, Holler E, Idzko M. Danger signals activating innate immunity in graft-versus-host disease. J Mol Med (Berl). 2011;89(9):833-845.
2. Jankovic D, Ganesan J, Bscheider M, et al. The Nlrp3 inflammasome regulates acute graft-versus-host disease. J Exp Med. 2013.
3.  Ostendorf BN, Blau O, Uharek L, Blau IW, Penack O. Association between low uric acid levels and acute graft-versus-host disease. Ann Hematol. 2015;94(1):139-144.



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

A Non-Interventional Prospective Study by the CMWP 

* Final call for data*
 
The collection of MED B/C and follow up data is well under way. The past months we have been receiving a lot of study forms and excel documents with the last data for your patients in this study. The last time points for the patients are expected in early Q4 2015. Please check whether you have submitted all forms for your patients and please check especially whether the MED C form was sent to us as this form contains the questions specific for 2nd generation TKIs.
 
 
We thank all participants for their ongoing cooperation in this important study!
 
MPN subcommittee of the CMWP
 
For  study forms 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

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.

Please submit your last cases

We are happy to inform you that at this moment over 600 episodes have been reported to us!
The IDWP thanks all participating centres for the wonderful effort they have put in.
 
* Please note that the inclusion of new patients continued until May 25th, 2015.*
 
This means that all participating centres should submit their cases of gram-negative bacteremia for all patients transplanted before 25 May 2015.
Patients transplanted until May 25th will have to be followed for 6 months to see if they develop a case.
 
The study will close on November 25th, 2015.
Med C forms of all bacteremic patients will need to be available during three months after each episode; for episodes occurring in the period September-November 2015 maximum at the end of December 2015.
Med A for all your transplanted patients during the study period (until 25 May 2015) will need to be available by the end of November.
 
When you have any questions or concerns,  please contact Jennifer Hoek of the EBMT Data Office via idwpebmt@lumc.nl 

The CALM study

Collaboration to Collect Autologous transplant outcomes in Lymphoma and Myeloma patients

Thank you!

Database lock baseline data
 
The database for baseline data has been locked the beginning of July. In total, 8100 MED-B and 8000 MED-C forms have been received!! We would like to thank you all for sending in your data and for the hard work you have done!  
 
Data collection follow up data
Data collection for the Follow-up data is still ongoing. Patients enrolled in 2008 and 2009 will be followed up until the end of 2014, while those enrolled from 2010 to 2012 will be followed up until the end of 2015.
 
* The data collection for the follow up data is still ongoing *
 
Annual follow up Deadline
Years 2008 - 2011 31 December 2014
Year 2012 31 December 2014
Year 2013 3rd quarter 2015
Year 2014 3rd quarter 2015
Year 2015 End of 2015
 
* Please send in you follow up data *  

Data quality Excel files
In July and August we have send out missing data files for the Follow Up data in the same way we have send the quality checks for the baseline data. The deadline to submit the Follow up file is November 01, 2015.  We will also send a helpful overview for the annual Follow Up forms, per year per patient.
 
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.

 
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