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
RACE trialPI’s: Regis Peffault de Latour, Antonio M Risitano
Clinical Trial Coordinator: Eline Smit/Ruzena Uddin
CMV Prophylaxis trialEBMT Steering Group: Per Ljungman, Rafael Duarte;
Recruitment ended in March 2016 and now Merck are analysing the data.
New Clinical Trial ProposalsIf you have a new proposal for a Clinical Trial for the CT2 committee or any questions about the proposal process please contact firstname.lastname@example.org.
Please consult the EBMT website for further information.
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 criteriaAll 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 collectionPatients 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 .
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 populationFirst 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 period01 May 2016 - 31 October 2017, with one year follow up.
Data collectionAll 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
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 period01 March 2016 – 28 February 2017 + 90 days follow up.
Inclusion criteria of the PcP cases:
Exclusion criteria of the PcP cases:
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.