ASTIC Autologous Stem Cell Transplantation for Crohn's Disease

This study has been terminated.
(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.)
Sponsor:
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: August 29, 2013
Last verified: August 2013
  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:


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: March 2017
Primary Completion Date: March 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

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297193

Locations
Belgium
University Hospital Gasthuisberg
Leuven, Herestraat 49, Belgium, 3000
Canada, Alberta
University of Calgery
Calgary, Alberta, Canada, T2N 2T9
France
Hopital Huriez Chru
Lille, France, 59037
Hospital Sanin-Louis
Paris, France, 75010
Italy
Universita di Bologna Interna e Gastroenterologia Policlinico Saint Orsola
Bologna, Italy, 40138
Dipatimento di Medicina Interna E Gastroenterologia
Bologna, Italy, 40138
Careggi Hospital
Florence, Italy, 50134
Istituto Clinico Humanitas
Milan, Italy, 20089
L Sacco University Hopsital
Milan, Italy, 20157
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Milan, Italy, 20122
Casa Sollievo Della Sofferenza IRCCS Hospital
San Giovanni Rotondo, Italy, 71013
Spain
Hospital Universitari Germans Trias I Pujol, Dept of Gastroenterology
Badalona, Spain, 08916
Switzerland
University Hospital
Basel, Switzerland, CH-4031
Universitätsspital Zürich
Zürich, Switzerland, 8091
United Kingdom
The John Radcliffe Hospital
Oxford, Headington, United Kingdom, OX3 9DU
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Barts and the London NHS Trust
London, United Kingdom, E1 1BB
Nottingham Digestive Diseases Centre
Nottingham, United Kingdom, NG7 2UH
City Hospital
Nottingham, United Kingdom, NG5 1PB
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: August 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 August 19, 2014