EBMT NEWSLETTER | March 2014 | Volume 40 - Issue 2

EBMT
Important dates

Retrospective study of the clinical activity of 5-Azacitidine in patients who have relapsed after allogeneic stem cell transplantation for Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS)

 
One year ago the Acute Leukaemia working party and MDS subcommittee of the Chronic Leukaemia working party of EBMTsupported by CELGENE Ltd, launched a  Retrospective the first registry analysis of the clinical activity of 5-Azacitdine in patients who relapse after an allogeneic transplant for Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS).
 
This retrospective study will characterise pre and post transplant factors associated with clinical response to 5-Azacitidine in all patients registered on the European Group for Blood and Marrow Transplantation (EBMT) database who received 5-Azacitdine for relapse after allogeneic stem cell transplantation for AML or MDS from 2000-2010.  
The objective of the study is to characterise the clinical activity of 5-Azacitidine (Vidaza) after relapse post allogeneic stem cell transplantation in patients with AML or MDS. Rate of response and survival are the, and Tolerability of 5-Azacitidine will be analyse, on adults patients with Acute Myeloid Leukaemia (AML) and Myelodysplastic Syndrome (MDS) in adults, who underwent BM or PB Allogeneic transplant perfomed from 2000 to 2010; and for whom Relapse post transplant was treated with 5-Azacitidine  
The treatment of relapse after transplant is not routinely collected in the EBMT registry. Therefore collection of information on patients who received 5-Azacitidine for treatment of relapse after an allogeneic transplantation proceed in 2 steps:  collection of the centre willingness to participate and patients identification, then scientific data collection  
Untill now  55 centres agreed to participate and 261 patients have been identified.
Identification step and data collection step are ongoing and we still count on your collaboration.
Your participation is welcome, please contact the EBMT Data Office Paris:

Email : emmanuelle.polge@upmc.fr
Tel : +33 1 71 97 04 85
Fax : +33 1 71 97 04 88

Combined Studies on NIMA/IPA Mismatches and Immune Biomarkers as Predictors of Clinical Outcome after HLA-Haploidentical Hematopoietic Stem Cell Transplantation.

Two combined retrospective studies by the IWP.

 

***  This study is still recruiting  ***

 
We are witnessing an unusual shift in stem cell donor selection; after two decades during which the choice for an allogeneic donor for a patient without a HLA identical sibling donor was limited to an unrelated adult donor or Cord Blood Unit, more and more Transplantation Centres report surprisingly good results obtained by the transplantation of haploidentical family donors. Little is yet known on the long term outcome of the patients which are receiving these haploidentical transplants now and the impact of secondary factors such as immune reconstitution and IPA and NIMA immunity and regulation on long term outcome.

Fortunately the EBMT Immunobiology Working Party had the foresight to activate a retrospective study of over 600 haematopoietic haploidentical transplants performed between January 1995 and June 2012 which can tell us to which extent these two variables can influence long term outcome.
 
We hope that you can agree with us that this an unique opportunity to collect and analyse this unique data set and hope that you will support this important project. Naturally, we will give full reference (authorship) to each participating institution when publishing the results of these studies.
 
When interested in participating in this unique study, please contact the EBMT Data Office in Leiden via IMMUNEWPebmt@lumc.nl
 

Call for data

For participating centres: please do not forget to send us your patient list and/or your completed excel file!

Thank you.

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.

 
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 62 centres are participating, aiming to collect 4700 transplants and 470 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.
 
 

***  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 .

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

A non-interventional prospective study by the CQLWP.

 

***  Announcement  ***

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 lead to a reduced incidence of GVHD (ASH 2012 Abstract 3063, Brunner et al.).

We are planning to conduct a prospective study to assess uric acid levels of patients undergoing allo-SCT and correlate them to clinical outcome. The study could contribute to a better understanding on 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.
 

Research Design:

Non-interventional prospective study. We aim to start by June 1st 2014. It is expected that recruitment will be closed by June 30th 2015. Follow up data will be requested.
 

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 and non-myeloablative conditioning
 

Collection:

Data from Med A; Data on GvHD from Med B; short Med C form.
 
For more information regarding this study, please contact the EBMT Data Office in Leiden via LEWPebmt@lumc.nl

Thank you.

Barriers & Facilitators to Discussing Sexual Issues Before and After HSCT.

A joint study between the CQWP and the Nurses Group of the EBMT.

 

***  This study is still recruiting  ***

There is evidence to suggest that survivors of HSCT who have not discussed potential and / or actual sexual concerns with their health-care provider experience a significant negative effect on their sexual function. (Humphreys et al. 2007). Only by knowing what the barriers and facilitators are to discussing concerns around sexuality can we help to improve sexual education as provided by health care providers.

A self-report questionnaire has been adapted to evaluate the barriers and facilitators for health care professionals discussing concerns around sexuality with people following Hematopoietic Stem Cell Transplantation (Moore et al, 2012).

The questionnaire is for doctors and nurses working in EBMT centres.

The questionnaire has been sent to EBMT centres in March in the form of an online survey. A paper version can be retrieved from the EBMT booth. You may also contact the EBMT Data Office in Leiden for the online or paper questionnaire and/or any questions regarding the study: LEWPebmt@lumc.nl

Thank you.

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 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. After collecting sufficient data we can start the analysis of this first prospective observational study on transfusion dependency and iron toxicity in MDS and CMML patients. Since the planned follow-up is 2 years after SCT we expect to perform the first full analysis in the first quarter of 2015.

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

 
The chart below shows that although most patients have been registered in the 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 the 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!


 
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