Open Surveys

As haematologists, we rarely treat patients of the demographic included in these vaccine clinical trials. In addition, there is a reporting bias within the literature favoured towards positive events, e.g. relapse AA. To study the impact of SARS-CoV-2 vaccination, a wider review for AA and/or PNH patients undergoing SARS-CoV-2 vaccination is proposed. You are kindly invited to join this study and contribute your patient data.

In view of the delays in vaccination in Europe, the registration period for this study has been extended to include all adult patients who have been invited for first vaccination by 30/06/2021. Patient registration will close on 30/07/2021.

Patients are eligible if:

1. they have been diagnosed with AA and/or PNH, irrespective of vaccination status;
2. they are under active follow-up (to allow CRF completion);
3. they have not yet undergone a bone marrow transplant.

Patients who are not eligible:

1. Patients who have undergone bone marrow transplant;
2. Paediatric patients due to vaccinations not currently being undertaken in this population, this may be revisited at a later date.

All required study forms are available below.

Patient registration can be performed before or after vaccination of the patient has started. For patients invited but not receiving vaccination, the reasons for this are of interest with a limited CRF completion at 3 months.

Data will be collected with a follow-up of 3-, 6- and 12-months post first vaccination. Because of the long follow-up, we would like to receive the CRF at two different timepoints: at 3 months and at 12 months post first vaccination. Please send your completed CRFs, password-secured, to Inge Verheggen at saawpebmt@lumc.nl.

On behalf of the IDWP and the SAAWP, thank you for your kind cooperation!

Morag Griffin – Principal Investigator
Peter Hillmen – International PNH interest Group and PNH registry Chair
Per Ljungman – Study Investigator
Inge Verheggen – COVID Team Data Manager
Dina Averbuch – IDWP Secretary
Rafael de la Camara – IDWP Chairperson
Antonio Risitano – SAAWP Secretary
Régis Peffault de Latour – SAAWP Chairperson

The SAAWP is currently conducting a retrospective study evaluating the use of androgens in BMF disorders in EBMT centers. Patients diagnosed with an inherited or acquired BMF between 2000 and 2019, and receiving an androgen-based treatment along their disease course, before or in the absence of allogeneic HSCT, are eligible for this study, regardless of their age. All patients receiving a transplant before androgen’s use do not qualify for this study.

We have identified more than 200 eligible patients in the EBMT registry. We are aiming to increase this sample size and have a more comprehensive outlook of the current use of these compounds in BMFs. If your centre wishes to participate, please contact Brian Piepenbroek at saawpebmt@lumc.nl to receive the study documents necessary to submit your patient data.

The impact of the new coronavirus SARS-CoV 2 on immunosuppressed patients such as stem cell transplant recipients and CAR-T cell recipients has been significant. However, there is still a lot of missing knowledge. The Infectious Diseases Working Party of the EBMT therefore has collected data since early March 2020. This activity is still ongoing and we believe it is of major importance to continue collecting information. We therefore hope you are willing to continue participating in the ongoing prospective survey about the impact of COVID-19 on patients having undergone stem cell or CAR T cell therapy in the data registration.

The survey is in 3 steps:

1. Please fill in the registration form for each patient diagnosed with covid-19 at your center and submit the completed form to the EBMT IDWP Data office. 
2. After resolution of the episode, we will collect more information regarding the COVID-19 infection and its outcome. Please fill in the follow-up form. 
3. We will thereafter merge the information with the MED-A form to get the basic patient information. Therefor, please make sure the patient is registered in the EBMT database

Extension of the inclusion

We also want to understand what happens if patients with a recent COVID-19 undergoes either stem cell transplantation or CAR T cell therapy. This is a complementary form to the registration form. If you have such patients, please fill in the form and thereafter also the follow-up form for such patients. If the number of patients exceed the number of slots on the form, please, add a 2nd form.

All the forms are available below and are protected with a password: covid_idwp

Contact

For any question about this survey, please email idwp.ebmt@lumc.nl. If you do not wish to participate, please let us know as well. 

Per Ljungman
Rafael de la Camara
Nicolaus Kröger
Jan Styczynski
Stephan Mielke
Malgorzata Mikulska

Patients who underwent HSCT, both allogeneic or autologous, between January 1st, 2021 and December 31st, 2022 and developed an infectious (any CTCAE grade) or relevant (CTCAE >1°) non-infectious CNS disorder after HSCT in this period can be included in this study. If you'd like to receive more information, or if you have an eligible patient, please contact the IDWP data office (email can be found below) and we will send you the registration form and all other required information to join our study.