ASTIC Autologous Stem Cell Transplantation for Crohn's Disease
NCT ID: NCT00297193
Last Updated: 2020-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
45 participants
INTERVENTIONAL
2006-06-30
2017-03-31
Brief Summary
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The purpose of this study is to determine whether there is a potential clinical benefit of hematopoietic stem cell mobilisation followed by high dose immuno-ablation and autologous stem cell transplantation versus hematopoietic stem cell mobilisation only followed by best clinical practice.
Detailed Description
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Patients will be randomised to:
* Hematopoietic stem cell mobilisation followed, within 4 weeks, by high dose immunoablation and autologous stem cell transplantation
* Hematopoietic stem cell mobilisation followed, after 59 weeks, by high dose immunoablation and autologous hematopoietic stem cell transplantation
All patients will be mobilised prior to randomisation. Those receiving early transplantation will be compared over the first year with those whose transplant has been delayed.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transplant Arm
Hematopoietic stem cell mobilisation followed, within 4 weeks, by high dose immunoablation and autologous stem cell transplantation
Autologous haematopoietic stem cell transplant
All patients will be mobilised prior to randomisation. Those receiving early transplantation will be compared over the first year with those whose transplant has been delayed.
Delayed Transplant
Hematopoietic stem cell mobilisation followed, after 59 weeks, by high dose immunoablation and autologous hematopoietic stem cell transplantation
Autologous haematopoietic stem cell transplant
All patients will be mobilised prior to randomisation. Those receiving early transplantation will be compared over the first year with those whose transplant has been delayed.
Interventions
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Autologous haematopoietic stem cell transplant
All patients will be mobilised prior to randomisation. Those receiving early transplantation will be compared over the first year with those whose transplant has been delayed.
Eligibility Criteria
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Inclusion Criteria
2. Confirmed diagnosis of active Crohn's Disease
3. Unsatisfactory course despite 3 immunosuppressive agents (usually azathioprine, methotrexate and infliximab) in addition to corticosteroids. Patients should have relapsing disease (i.e. \>1 exacerbation/year) despite thiopurines, methotrexate and/or infliximab maintenance therapy or clear demonstration of intolerance / toxicity to these drugs.
4. Impaired function and quality of life, compared to population means, on at least one of the following:
1. IBDQ (Appendix 6)
2. European Questionnaire of Life quality (EuroQOL-5D, Appendix 4)
3. Impaired function on Karnofsky index (Appendix 7)
5. Current problems unsuitable for surgery and patient at risk for developing short bowel syndrome.
6. Informed consent
1. Wherever possible, diseased tissue should be accessible endoscopically for objective histological study but in the case of small bowel disease that is extensive but does not extend to duodenum or terminal ileum, participation without endoscopy is allowed.
2. Smokers may enter the study provided they have received intensive counselling about smoking.
3. Add patients with ileostomy/colostomy and patients with short bowel syndrome
Exclusion Criteria
2. Concomitant severe disease
3. Diarrhoea due to short small or large bowel
4. Infection or risk thereof
5. Significant malnutrition: Body Mass Index (BMI) ≤18, serum albumin \<20 g/l
6. Previous poor compliance
7. Concurrent enrolment in any other protocol using an investigational drug or hematopoietic growth factor up to four weeks before study entry.
8. Lack of funding
18 Years
65 Years
ALL
No
Sponsors
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The Broad Foundation
OTHER
European Society for Blood and Marrow Transplantation
NETWORK
Responsible Party
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Principal Investigators
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Christopher J Hawkey
Role: STUDY_CHAIR
Nottingham University Hospital - Wolfson Digestive Diseases Centre
Locations
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University Hospital Gasthuisberg
Leuven, Herestraat 49, Belgium
University of Calgery
Calgary, Alberta, Canada
Hopital Huriez Chru
Lille, , France
Hospital Sanin-Louis
Paris, , France
Dipatimento di Medicina Interna E Gastroenterologia
Bologna, , Italy
Universita di Bologna Interna e Gastroenterologia Policlinico Saint Orsola
Bologna, , Italy
Careggi Hospital
Florence, , Italy
Istituto Clinico Humanitas
Milan, , Italy
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Milan, , Italy
L Sacco University Hopsital
Milan, , Italy
Casa Sollievo Della Sofferenza IRCCS Hospital
San Giovanni Rotondo, , Italy
Hospital Universitari Germans Trias I Pujol, Dept of Gastroenterology
Badalona, , Spain
University Hospital
Basel, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
The John Radcliffe Hospital
Oxford, Headington, United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Barts and the London NHS Trust
London, , United Kingdom
City Hospital
Nottingham, , United Kingdom
Nottingham Digestive Diseases Centre
Nottingham, , United Kingdom
Countries
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References
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Lindsay JO, Allez M, Clark M, Labopin M, Ricart E, Rogler G, Rovira M, Satsangi J, Farge D, Hawkey CJ; ASTIC trial group; European Society for Blood and Marrow Transplantation Autoimmune Disease Working Party; European Crohn's and Colitis Organisation. Autologous stem-cell transplantation in treatment-refractory Crohn's disease: an analysis of pooled data from the ASTIC trial. Lancet Gastroenterol Hepatol. 2017 Jun;2(6):399-406. doi: 10.1016/S2468-1253(17)30056-0. Epub 2017 Apr 6.
Hawkey CJ, Allez M, Clark MM, Labopin M, Lindsay JO, Ricart E, Rogler G, Rovira M, Satsangi J, Danese S, Russell N, Gribben J, Johnson P, Larghero J, Thieblemont C, Ardizzone S, Dierickx D, Ibatici A, Littlewood T, Onida F, Schanz U, Vermeire S, Colombel JF, Jouet JP, Clark E, Saccardi R, Tyndall A, Travis S, Farge D. Autologous Hematopoetic Stem Cell Transplantation for Refractory Crohn Disease: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2524-34. doi: 10.1001/jama.2015.16700.
Other Identifiers
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ASTIC
Identifier Type: -
Identifier Source: secondary_id
EudraCT2005-003337-40
Identifier Type: -
Identifier Source: org_study_id