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Be Part of Research - Trial Details - Randomized Study In Severe Aplastic Anemia Patients Receiving Atg, Cyclosporin A, With Or Without G-CSF (SAA-G-CSF)
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Randomized Study In Severe Aplastic Anemia Patients Receiving Atg, Cyclosporin A, With Or Without G-CSF (SAA-G-CSF)

Stopped

Open to: ALL

Age: 2.0 - 90.0

Birmingham Airdrie Bristol London London Cornwall Leeds Wishaw

Medical Conditions

Anemia
Anemia, Aplastic

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The purpose of this study is to examine the effect of G-CSF on disease free survival and overall survival in aplastic anaemia patients who also receive ATG and Cyclosporin A.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Mar 2001 Jun 2008

Publications

"Tichelli A, de Latour RP, Passweg J, Knol-Bout C, Socie G, Marsh J, Schrezenmeier H, Hochsmann B, Bacigalupo A, Samarasinghe S, Rovo A, Kulasekararaj A, Roth A, Eikema DJ, Bosman P, Bader P, Risitano A, Dufour C; SAA Working Party of the EBMT. Long-term outcome of a randomized controlled study in patients with newly diagnosed severe aplastic anemia treated with antithymocyte globulin and cyclosporine, with or without granulocyte colony-stimulating factor: a Severe Aplastic Anemia Working Party Trial from the European Group of Blood and Marrow Transplantation. Haematologica. 2020 May;105(5):1223-1231. doi: 10.3324/haematol.2019.222562. Epub 2019 Oct 3."; "31582549"; "Tichelli A, Schrezenmeier H, Socie G, Marsh J, Bacigalupo A, Duhrsen U, Franzke A, Hallek M, Thiel E, Wilhelm M, Hochsmann B, Barrois A, Champion K, Passweg JR. A randomized controlled study in patients with newly diagnosed severe aplastic anemia receiving antithymocyte globulin (ATG), cyclosporine, with or without G-CSF: a study of the SAA Working Party of the European Group for Blood and Marrow Transplantation. Blood. 2011 Apr 28;117(17):4434-41. doi: 10.1182/blood-2010-08-304071. Epub 2011 Jan 13."; "21233311"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Yes/no addition of G-CSF

Intervention Arm Group : No G-CSF, No 2nd ATG;No G-CSF, yes 2nd ATG;Yes G-CSF, No 2nd ATG;Yes G-CSF, Yes 2nd ATG;

Intervention Type : DRUG
Intervention Description : Yes/no early retreatment with ATG

Intervention Arm Group : No G-CSF, No 2nd ATG;No G-CSF, yes 2nd ATG;Yes G-CSF, No 2nd ATG;Yes G-CSF, Yes 2nd ATG;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Heartlands Hospital
    Birmingham
  • Monklands Hospital
    Airdrie
  • Bristol Haematology & Oncology Centre
    Bristol
  • St George's Hospital/ St George's University of London
    London
    Sw17 0RE
  • St. Bartholomew's Hospital
    London
  • Royal Cornwall Hospitals
    Cornwall
  • The Leeds Teaching Hospitals
    Leeds
  • Wishaw General
    Wishaw


The study is sponsored by European Society for Blood and Marrow Transplantation and is in collaboration with CHUGAI sanofi-aventis.



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Read full details for Trial ID: NCT01163942
Last updated 19 February 2024

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