Crohn DiseasePhase 3NCT00297193
ASTIC Autologous Stem Cell Transplantation for Crohn's Disease
A Phase 3 study testing Autologous haematopoietic stem cell transplant in people with Crohn Disease, run by European Society for Blood and Marrow Transplantation at 19 sites in 7 countries.
Trial summary
Transplant study for patients with relapsing Crohn's disease demonstrating clear intolerance or toxicity to conventional treatment. 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Autologous haematopoietic stem cell transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 19 sitesin 7 countries
- Study dates
- Jun 2006to Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 50 years (Patients aged 50-65 can participate if specially approved by the Trial Steering Committee)
- Confirmed diagnosis of active Crohn's Disease
- 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.
- Impaired function and quality of life, compared to population means, on at least one of the following:
- IBDQ (Appendix 6)
- European Questionnaire of Life quality (EuroQOL-5D, Appendix 4)
Show all 12Show fewer
- Impaired function on Karnofsky index (Appendix 7)
- Current problems unsuitable for surgery and patient at risk for developing short bowel syndrome.
- Informed consent
- 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.
- Smokers may enter the study provided they have received intensive counselling about smoking.
- Add patients with ileostomy/colostomy and patients with short bowel syndrome
Who cannot join
- Pregnancy or unwillingness to use adequate contraception during the study
- Concomitant severe disease
- Diarrhoea due to short small or large bowel
- Infection or risk thereof
- Significant malnutrition: Body Mass Index (BMI) ≤18, serum albumin <20 g/l
- Previous poor compliance
- Concurrent enrolment in any other protocol using an investigational drug or hematopoietic growth factor up to four weeks before study entry.
- Lack of funding
Trial locations and contacts
19 sites in 7 countries.
19 sites in 7 countries
Italy7 sites
Dipatimento di Medicina Interna E Gastroenterologia
Bologna, 40138
Universita di Bologna Interna e Gastroenterologia Policlinico Saint Orsola
Bologna, 40138
Careggi Hospital
Florence, 50134
Istituto Clinico Humanitas
Milan, 20089
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Milan, 20122
L Sacco University Hopsital
Milan, 20157
Casa Sollievo Della Sofferenza IRCCS Hospital
San Giovanni Rotondo, 71013
United Kingdom5 sites
Western General Hospital
Edinburgh, EH4 2XU
Barts and the London NHS Trust
London, E1 1BB
City Hospital
Nottingham, NG5 1PB
Nottingham Digestive Diseases Centre
Nottingham, NG7 2UH
The John Radcliffe Hospital
Oxford, Headington, OX3 9DU
France2 sites
Hopital Huriez Chru
Lille, 59037
Hospital Sanin-Louis
Paris, 75010
Switzerland2 sites
University Hospital
Basel, CH-4031
Universitätsspital Zürich
Zurich, 8091
Spain1 site
Hospital Universitari Germans Trias I Pujol, Dept of Gastroenterology
Badalona, 08916
About this study
Official title: Autologous Stem Cell Transplantation for Crohn's Disease: ASTIC
Transplant study for patients with relapsing Crohn's disease demonstrating clear intolerance or toxicity to conventional treatment.
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.
Read the detailed description
Open label, phase III, randomised, multicentre study comparing early transplantation procedure with transplantation carried out to the same protocol but delayed by one year. The status of patients undergoing early HSCT will be evaluated after one year and compared to those about to undergo delayed HSCT
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
- Crohn Disease
- Being tested
- Autologous haematopoietic stem cell transplant
- Keywords
- Crohn's Disease, HSCT, Autologous, EBMT, ECCO
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous haematopoietic stem cell transplantProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Transplant Arm | Experimental | Hematopoietic stem cell mobilisation followed, within 4 weeks, by high dose immunoablation and autologous stem cell transplantation Receives: Procedure: Autologous haematopoietic stem cell transplant |
| Delayed Transplant | Experimental | Hematopoietic stem cell mobilisation followed, after 59 weeks, by high dose immunoablation and autologous hematopoietic stem cell transplantation Receives: Procedure: Autologous haematopoietic stem cell transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion patients in sustained disease remission
To evaluate the 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 in patients with Crohn' s disease.
Measured: 1 year
Secondary outcomes (1)
patients who have not responded to immunosuppressant medication
To evaluate the safety of Hematopoietic Stem Cell Transplantation (HSCT) in Crohn's disease patients who have not responded to immunosuppressant medication
Measured: 1 - 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2013
- Study completionMar 2017
Why it stopped: For safety reasons the recruitment was halted prematurely. Patients on the trial continute to receive treatment and are being followed up as part the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society for Blood and Marrow Transplantation
- Sponsor type
- Research network
- Collaborators
- The Broad Foundation
- Responsible party
- Sponsor
- Investigators
- Christopher J Hawkey, Study chair, Nottingham University Hospital - Wolfson Digestive Diseases Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297193
- Sponsor's protocol ID
- EudraCT2005-003337-40
- Other IDs
- ASTIC
- Status last verified
- Aug 2013
- First submitted
- 27 Feb 2006
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28497755Hawkey 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.
PubMed 26670970
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Stem Cell Transplantation for Crohn's Disease: ASTIC
- ClinicalTrials.gov ID
- NCT00297193
- Acronym / sponsor ID
- EudraCT2005-003337-40
- Conditions
- Crohn Disease
- Keywords
- Crohn's Disease, HSCT, Autologous, EBMT, ECCO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For safety reasons the recruitment was halted prematurely. Patients on the trial continute to receive treatment and are being followed up as part the protocol.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- European Society for Blood and Marrow TransplantationResearch network
- Collaborators
- The Broad Foundation
- Study start
- Jun 2006
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 28 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transplant study for patients with relapsing Crohn's disease demonstrating clear intolerance or toxicity to conventional treatment.
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
Open label, phase III, randomised, multicentre study comparing early transplantation procedure with transplantation carried out to the same protocol but delayed by one year. The status of patients undergoing early HSCT will be evaluated after one year and compared to those about to undergo delayed HSCT
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transplant Arm | Experimental | Procedure: Autologous haematopoietic stem cell transplantHematopoietic stem cell mobilisation followed, within 4 weeks, by high dose immunoablation and autologous stem cell transplantation |
| Delayed Transplant | Experimental | Procedure: Autologous haematopoietic stem cell transplantHematopoietic stem cell mobilisation followed, after 59 weeks, by high dose immunoablation and autologous hematopoietic stem cell transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 18 and 50 years (Patients aged 50-65 can participate if specially approved by the Trial Steering Committee)
- Confirmed diagnosis of active Crohn's Disease
- 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.
- Impaired function and quality of life, compared to population means, on at least one of the following:
- Current problems unsuitable for surgery and patient at risk for developing short bowel syndrome.
Key exclusion criteria (8 listed)
- Pregnancy or unwillingness to use adequate contraception during the study
- Concomitant severe disease
- Diarrhoea due to short small or large bowel
- Infection or risk thereof
- Significant malnutrition: Body Mass Index (BMI) ≤18, serum albumin <20 g/l
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous haematopoietic stem cell transplantAll 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. | Procedure or surgery | Delayed Transplant, Transplant Arm |
Primary outcome
Proportion patients in sustained disease remission
Time frame: 1 year
To evaluate the 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 in patients with Crohn' s disease.
1 secondary outcome
patients who have not responded to immunosuppressant medication
Time frame: 1 - 2 years
Results and safety
The study was stopped early (reason given: For safety reasons the recruitment was halted prematurely. Patients on the trial continute to receive treatment and are being followed up as part the protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Derived from this study: PubMed 28497755Lindsay 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.
- Derived from this study: PubMed 26670970Hawkey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Hawkey study chair
Nottingham University Hospital - Wolfson Digestive Diseases Centre
19 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous haematopoietic stem cell transplant in people with Crohn Disease, run by European Society for Blood and Marrow Transplantation at 19 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy, United Kingdom, France, Switzerland, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: For safety reasons the recruitment was halted prematurely. Patients on the trial continute to receive treatment and are being followed up as part the protocol.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion patients in sustained disease remission (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00297193, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.