ASTIC Autologous Stem Cell Transplantation for Crohn's Disease
This study is ongoing, but not recruiting participants.
Sponsor:
European Group for Blood and Marrow Transplantation
Collaborator:
The Broad Foundation
Information provided by (Responsible Party):
European Group for Blood and Marrow Transplantation
ClinicalTrials.gov Identifier:
NCT00297193
First received: February 27, 2006
Last updated: April 29, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn Disease |
Procedure: Autologous haematopoietic stem cell transplant |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Autologous Stem Cell Transplantation for Crohn's Disease: ASTIC |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
U.S. FDA Resources
Further study details as provided by European Group for Blood and Marrow Transplantation:
Primary Outcome Measures:
- Proportion patients in sustained disease remission [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- patients who have not responded to immunosuppressant medication [ Time Frame: 1 - 2 years ] [ Designated as safety issue: Yes ]To evaluate the safety of Hematopoietic Stem Cell Transplantation (HSCT) in Crohn's disease patients who have not responded to immunosuppressant medication
Other Outcome Measures:
- Impact of HSCT on health related, and generic, quality of life measures [ Time Frame: 1 - 2 Years ] [ Designated as safety issue: No ]To evaluate the impact of HSCT on health related, and generic, quality of life measures
- To identify factors predictive of success [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]To identify factors predictive of success
| Enrollment: | 45 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Transplant Arm
Hematopoietic stem cell mobilisation followed, within 4 weeks, by high dose immunoablation and autologous stem cell transplantation
|
Procedure: 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.
|
|
Experimental: Delayed Transplant
Hematopoietic stem cell mobilisation followed, after 59 weeks, by high dose immunoablation and autologous hematopoietic stem cell transplantation
|
Procedure: 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Inclusion criteria: mandatory
- 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)
- SF-36 Appendix 5)
- Impaired function on Karnofsky index (Appendix 7)
- Current problems unsuitable for surgery and patient at risk for developing short bowel syndrome.
- Informed consent
Inclusion criteria: discretionary
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297193
Locations
| Czech Republic | |
| General Faculty HospitalI, Vth Medical Dept | |
| Prague, Czech Republic, 12808 | |
| France | |
| Hospital Sanin-Louis | |
| Paris, France, 75010 | |
| Germany | |
| University of Freiburg, Medical Center | |
| Freiburg, Germany | |
| Italy | |
| Universita di Bologna Interna e Gastroenterologia Policlinico Saint Orsola | |
| Bologna, Italy, 40138 | |
| Netherlands | |
| Academic Medical Center Dept of Gastroenterology & Hepatology | |
| Amsterdam, Netherlands, 1105 | |
| Spain | |
| Hospital Universitari Germans Trias I Pujol, Dept of Gastroenterology | |
| Badalona, Spain, 08916 | |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois, Division of Gastroenterology | |
| Lausanne, Switzerland, 1010 | |
| United Kingdom | |
| Wolfson Digestive Diseases Centre - University Hospital | |
| Nottingham, United Kingdom, NG7 2UH | |
Sponsors and Collaborators
European Group for Blood and Marrow Transplantation
The Broad Foundation
Investigators
| Study Chair: | Christopher J Hawkey | Nottingham University Hospital - Wolfson Digestive Diseases Centre |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Group for Blood and Marrow Transplantation |
| ClinicalTrials.gov Identifier: | NCT00297193 History of Changes |
| Other Study ID Numbers: | EudraCT2005-003337-40, ASTIC |
| Study First Received: | February 27, 2006 |
| Last Updated: | April 29, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Paul-Ehrlich-Institut France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Italy: Ministry of Health Spain: Spanish Agency of Medicines Switzerland: Swissmedic |
Keywords provided by European Group for Blood and Marrow Transplantation:
|
Crohn's Disease HSCT Autologous EBMT ECCO |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013