EBMT NEWSLETTER | September 2016 | Volume 53 - Issue 4

EBMT
Important dates
Content:
Prospective clinical trials
- RACE trial
- CMV Prophylaxis trial
- New Clinical Trial proposals
Current Treatment of HCV Infection after HSCT
IPAT: Impact of Pre-existing invasive Aspergillosis on allogeneic stem cell Transplantation
Pneumocystis Jirovecii Pneumonia (PcP) after Allogeneic HSCT

Prospective clinical trials

The EBMT Clinical Trials Office is currently working on one prospective clinical trial in addition to the older trials that are in long-term follow-up.

RACE trial 

PI’s: Regis Peffault de Latour, Antonio M Risitano
Sponsor: EBMT
Clinical Trial Coordinator: Eline Smit/Ruzena Uddin
  • The first patient was recruited into this trial in July 2015 in St. Louis Hospital in Paris
  • 34 patients have been recruited across 13 open centres. A total of 200 patients are required for this trial
  • The countries open for recruitment are France, Italy, Netherlands, Spain and the UK
  • Approvals are in process for Switzerland
  • The participation of German centres is on hold
  • It is hoped that all centres will be open by October 2016 (depending on approvals)

CMV Prophylaxis trial 

EBMT Steering Group: Per Ljungman, Rafael Duarte; 
Sponsor: Merck
Recruitment ended in March 2016 and now Merck are analysing the data.  

New Clinical Trial Proposals

If you have a new proposal for a Clinical Trial for the CT2 committee or any questions about the proposal process please contact liz.clark@ebmt.org.
Please consult the EBMT website for further information. 

Current Treatment of HCV Infection after HSCT

IDWP non-interventional prospective study

*** Recruiting ***
 
PI: Malgorzata Mikulska
 
When you have a patient with HCV infection, please contact the IDWP Data Office via IDWPebmt@LUMC.nl

The availability of novel therapies with oral directly acting antivirals might prompt clinicians caring for HCV-positive HSCT recipients to prescribe the treatment more frequently and possibly earlier after HSCT.

This study will focus on treatment strategies in HCV-positive HSCT recipients and might provide additional data compared to previous older cohorts in the area of non-invasive assessment of fibrosis, HCV-RNA levels and genotyping. The main focus is the rate of treatment, the combination of drugs chosen, the length of treatment and the outcome.

Inclusion criteria

All HCV-RNA positive patients  cared for between December 2015 and  November 2017, who underwent HSCT (auto or allo) from any time to May 2017 .

Data collection

Patients not on treatment: 1 baseline form, 1 follow-up form at end of study.
Patients on treatment: 1 treatment form, 1 follow-up form 6 months after the end of treatment .

IPAT: Impact of Pre-existing invasive Aspergillosis on allogeneic stem cell Transplantation

IDWP non-interventional prospective study

*** Recruiting***

PI: Olaf Penack

01 May 2016 - 31 October 2017

In patients with pre-existing invasive aspergillosis (IA) allo-SCT is feasible without progression of fungal infection. However, the influence of invasive mould infections on transplant related complications and on long term survival has not been investigated in a larger patient cohort under current conditions.

With this non-interventional prospective study we want to assess clinical outcome of patients with —and without— history of pre-existing  IA undergoing allo-HSCT, in terms of non-relapse mortality, overall mortality and fungal infectious morbidity.

Study population

First allo-HSCT in patients with acute leukaemia and MDS given stem cell grafts.
            Cohort 1: History of probable or proven invasive aspergillosis
            Cohort 2: No History of probable or proven invasive aspergillosis.

Study period

01 May 2016 - 31 October 2017, with one year follow up.

Data collection

All patients: new MED A; Patient Registration Form; MED C follow up forms.
Only for patients with proven/probable IA and additional form needs to be completed.
 
When interested in participation, please contact the IDWP Data Office via
IDWPebmt@LUMC.nl

Pneumocystis Jirovecii Pneumonia (PcP) after Allogeneic HSCT

IDWP non-interventional prospective study

 ***Recruiting***
 
PI: Christine Robin

01 March 2016 - 01 March 2017

When you have a patient with PcP infection, please contact the IDWP Data Office via IDWPebmt@LUMC.nl

We aim to collect 100 cases. The study is open to EBMT centres using BAL for the diagnosis of PcP. You may participate even when you have no pneumocystis PCR on site.

Study period

01 March 2016 – 28 February 2017 + 90 days follow up.

Inclusion criteria of the PcP cases:

  • Allogeneic HSCT within the previous 24 months
  • New case (first onset) of PcP documented  in a BAL fluid, whatever the positive diagnostic test (cytology or IF or PCR) and whatever the presentation and treatment
  • Any age
  • Pre-or post-transplant informed consent to enter the data in the EBMT registry.

Exclusion criteria of the PcP cases:

  • Autologous HSCT
  • Allogeneic HSCT recipient transplanted more than 24 months before the onset of PcP
  • Second episode of PcP since allogeneic HSCT (patients diagnosed with PcP before allogeneic HSCT are not excluded).
The study aims at identifying risk factors, timing and diagnostic methods of PcP after allogeneic HSCT within the EBMT. It consists of a prospective 12-months collection of new PcP cases occurring in the 24 months following an allogeneic HSCT. PcP is defined by any positive specific criteria in BAL (cytology or IF or PCR), whatever the clinical presentation and whether the patient has been treated or not. We will ask you for each PcP case to fill a specific short MedC. The IDWP data office will identify in your centre 2 control cases for one case of PcP and you will be asked to fill a short Med C for each of these controls. MED A registration of these patients is required.
The number of cases per EBMT centre during the last years is very low (0 up to 7 in very big centres) and this study represents few work for the centres, but may provide major information if most EBMT centres participate.
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