ASTIC Autologous Stem Cell Transplantation for Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Autologous Stem Cell Transplantation for Crohn's Disease: ASTIC

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00297193
• Other study ID #: EudraCT2005-003337-40
• Secondary ID: ASTIC
• Status: Terminated
• Phase: Phase 3
• Start date: June 2006
• Est. completion date: March 2017

Study information

• Verified date: August 2013
• Source: European Group for Blood and Marrow Transplantation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 cell transplantation versus hematopoietic stem cell mobilisation only followed by best clinical practice.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: March 2017
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Inclusion criteria: mandatory

1. Age between 18 and 50 years (Patients aged 50-65 can participate if specially approved by the Trial Steering Committee)

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

Inclusion criteria: discretionary

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:

1. Pregnancy or unwillingness to use adequate contraception during the study

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospital Gasthuisberg	Leuven	Herestraat 49
Canada	University of Calgery	Calgary	Alberta
France	Hopital Huriez Chru	Lille
France	Hospital Sanin-Louis	Paris
Italy	Dipatimento di Medicina Interna E Gastroenterologia	Bologna
Italy	Universita di Bologna Interna e Gastroenterologia Policlinico Saint Orsola	Bologna
Italy	Careggi Hospital	Florence
Italy	Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena	Milan
Italy	Istituto Clinico Humanitas	Milan
Italy	L Sacco University Hopsital	Milan
Italy	Casa Sollievo Della Sofferenza IRCCS Hospital	San Giovanni Rotondo
Spain	Hospital Universitari Germans Trias I Pujol, Dept of Gastroenterology	Badalona
Switzerland	University Hospital	Basel
Switzerland	Universitätsspital Zürich	Zürich
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	The John Radcliffe Hospital	Oxford	Headington

Sponsors (2)

Lead Sponsor	Collaborator
European Group for Blood and Marrow Transplantation	The Broad Foundation

Countries where clinical trial is conducted

Belgium,  Canada,  France,  Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of HSCT on health related, and generic, quality of life measures	To evaluate the impact of HSCT on health related, and generic, quality of life measures	1 - 2 Years
Other	To identify factors predictive of success	To identify factors predictive of success	1-2 years
Primary	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.	1 year
Secondary	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	1 - 2 years