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Activity text Aplastic Anaemia - AA
Short Title |
RATGAA07
|
EudraCT Number |
2007-000902-55 |
Disease(s) |
Aplastic AnaemiaRATGAA07 |
Working Party |
AAWP |
Phase |
II |
Study status |
Completed patient recruitment |
Full Title |
Prospective Phase II Pilot study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin: a Study from the European Blood and Marrow Transplant (EBMT) Severe Aplastic Anaemia Working Party. |
Start Date |
2007 |
End date |
2012 |
Study design |
Non-randomized, prospective, multi-centre, phase II pilot study. |
Primary objective |
To assess the tolerability and efficacy of rabbit antithymocyte globulin (ATG, Thymoglobuline®) with ciclosporin (CSA) in the first line treatment of patients with acquired severe aplastic anaemia (SAA), and patients with non-severe aplastic anaemia (NSAA) and who are transfusion dependent.
To compare the response rate of the combination of rabbit ATG (Thymoglobuline® and CSA from this pilot study with the response rate observed in a series of matched AA patients; treated after 1994 with the combination of horse ATG (Lymphoglobuline®) and CSA; obtained from the EBMT database. |
Population Age |
≥ 16 years (18 in DE + CH) |
Gender |
Male/Female |
Target sample size |
35 |
Countries |
France, Germany, Italy, Saudi Arabia, Switzerland, United Kingdom |
Chief Investigator |
Prof Judith Marsh |
EBMT contact |
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Links
Publication |
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Last update |
Februari 2013 |
Acute Myeloid Leukaemia - AML
Short Title |
HCT vs CT in Elderly AML |
EudraCT Number |
2007-003514-34 |
Disease(s) |
AML |
Working Party |
ALWP |
Phase |
III |
Study status |
Recruiting patients |
Full Title |
A Randomized Phase III study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission |
Start Date |
2010 |
End date |
2019 |
Study design |
Randomised, controlled, open, multicentre, phase III trial |
Primary objective |
Efficacy of allogeneic related or unrelated hematopoietic cell transplantation (HCT) after reduced intensity conditioning as a consolidation treatment for elderly patients with AML in complete remission. |
Population Age |
≥60 and ≤75 years |
Gender |
Male/Female |
Target sample size |
231 randomised patients |
Countries |
Australia, Austria, Belgium, France, Germany, Netherlands & Switzerland |
Chief Investigator |
Dietger Niederwieser |
EBMT contact |
|
Links |
|
Last update |
October 2012 |
Autoimmune diseases
Short Title |
ASTIC |
EudraCT Number |
2005-003337-40 |
Disease(s) |
Crohn’s Disease |
Working Party |
ADWP |
Phase |
III |
Study status |
Completed patient recruitment |
Full Title |
Autologous Stem Cell Transplantation International Crohn's Disease Trial: a multicentre, prospective, randomised phase II study conducted by the European Crohn’s and Colitis Organisation (ECCO), sponsored by the Autoimmune Disease Working Party of the European Group for Blood and Marrow Transplantation (EBMT) |
Start Date |
2007 |
End date |
2013 |
Study design |
Open label, randomised, multicentre study |
Primary objective |
To evaluate the potential clinical benefit of hematopoietic stem cell mobilisation followed by high dose immunoablation and autologous stem cell transplantation versus hematopoietic stem cell mobilisation only followed by best clinical practice in patients with Crohn' s disease |
Population Age |
18-50 years |
Gender |
Male/Female |
Target sample size |
48 |
Countries |
UK, France, Czech Republic, Germany, Italy, Spain, Switzerland, Canada |
Chief Investigator |
Prof Christopher J Hawkey |
EBMT contact |
|
Links |
|
Last update |
August 2012 |
Short Title |
ASTIS |
EudraCT Number |
2006-004598-83 |
Disease(s) |
Systemic Sclerosis |
Working Party |
ADWP |
Phase |
III |
Study status |
Completed patient recruitment |
Full Title |
High dose immunoablation and autologous hematopoietic stem cell transplantation versus monthly intravenous pulse therapy cyclophosphamide in severe systemic sclerosis |
Start Date |
2001 |
End date |
2016 |
Study design |
Multicentre, randomized, controlled trial |
Primary objective |
To evaluate the potential clinical benefit of high dose immunoablation and autologous stem cell transplantation in comparison to intravenous pulse therapy cyclophosphamide, with respect to survival and prevention of major organ failure, safety, impact on skin thickening, visceral involvement, functional status, and quality of life. |
Population Age |
18-65 |
Gender |
Male/Female |
Target sample size |
150 |
Countries |
Austria, Belgium, Canada, France, Germany, Greece, Italy, Netherlands, Switzerland & UK |
Chief Investigator |
J.M. van Laar |
EBMT contact |
|
Links |
|
Last update |
August 2012 |
Infectious diseases
Short Title |
Convince |
EudraCT Number |
2009-015965-29 |
Disease(s) |
CMV Infection |
Working Party: |
IDWP |
Phase |
III |
Study status |
Terminated |
Full Title |
Multicentre, randomized study comparing oral valganciclovir versus intravenous ganciclovir in patients following allogeneic stem cell transplantation |
Start Date |
2010 |
End date |
December 2011 |
Study design |
Multicentre, multinational, randomised, open-label clinical therapy study with 2 parallel groups |
Primary objective |
To assess the efficacy and safety of oral valganciclovir versus intravenous (i.v.) ganciclovir in patients following allogeneic stem cell transplantation |
Population Age |
≥18 years |
Gender |
Male/Female |
Target sample size |
212 |
Countries |
Germany, Switzerland, Austria, Spain, France |
Chief Investigator |
Prof. Dr. med. Hermann Einsele |
EBMT contact |
|
Links |
|
Last update |
August 2012 |
Multiple myeloma
Short Title |
MMVAR |
EudraCT Number |
2005-001628-35 |
Disease(s) |
Multiple Myeloma |
Working Party |
CLWP |
Phase |
III |
Study status |
Completed patient recruitment |
Full Title |
A Randomized controlled study of Velcade (Bortezomib) plus Thalidomide plus Dexamethasone compared to Thalidomide plus Dexamethasone for the treatment of myeloma patients progressing or relapsing after autologous transplantation (MMVAR) |
Start Date |
2005 |
End date |
2013 |
Study design |
Randomized, parallel-group, open–label, multicentre study |
Primary objective |
Test the hypothesis that treatment with Velcade plus Thalidomide plus Dexamethasone in combination, will result in a longer time to progression than Thalidomide plus Dexamethasone in subjects with relapsed or progressive myeloma after autologous transplantation |
Population Age |
≥ 18 years |
Gender |
Male/Female |
Target sample size |
269 |
Countries |
France, Belgium, Germany, Switzerland, Austria, Italy, Czech Republic, Hungary, Israel, and the UK |
Chief Investigator |
Dr Laurent Garderet |
EBMT contact |
|
Links |
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Last update |
August 2012 |
Myelodysplastic syndromes - MDS
Short Title |
RICMAC |
EudraCT Number |
2005-002011-24 |
Disease(s) |
MDS or sAML |
Working Party |
CLWP |
Phase |
III |
Study status |
Recruiting patients |
Full Title |
Dose-reduced versus standard conditioning followed by allogeneic stem cell transplantation in patients with MDS or sAML: A randomised phase III study |
Start Date |
2004 |
End date |
2014 |
Study design |
Prospective randomised phase III multi-centre study |
Primary objective |
The hypothesis is that a dose-reduced conditioning will reduce the non-relapse mortality from 40 % to 20 % at one year after allogeneic stem cell transplantation |
Population Age |
18-65 |
Gender |
Male/Female |
Target sample size |
160 |
Countries |
Belgium, Finland, France, Germany, Italy, Russia, Switzerland |
Chief Investigator |
Prof. Dr. N. Kröger |
EBMT contact |
|
Links |
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Last update |
October 2012 |
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