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Trial record 1 of 1 for:    ASTIC
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ASTIC Autologous Stem Cell Transplantation for Crohn's Disease

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ClinicalTrials.gov Identifier: NCT00297193
Recruitment Status : 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.)
First Posted : February 28, 2006
Last Update Posted : December 22, 2020
Sponsor:
Collaborator:
The Broad Foundation
Information provided by (Responsible Party):
European Society for Blood and Marrow Transplantation

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Crohn Disease Procedure: Autologous haematopoietic stem cell transplant Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Stem Cell Transplantation for Crohn's Disease: ASTIC
Study Start Date : June 2006
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. patients who have not responded to immunosuppressant medication [ Time Frame: 1 - 2 years ]
    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:
  1. Impact of HSCT on health related, and generic, quality of life measures [ Time Frame: 1 - 2 Years ]
    To evaluate the impact of HSCT on health related, and generic, quality of life measures

  2. To identify factors predictive of success [ Time Frame: 1-2 years ]
    To identify factors predictive of success


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00297193


Locations
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Sponsors and Collaborators
European Society for Blood and Marrow Transplantation
The Broad Foundation
Investigators
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Study Chair: Christopher J Hawkey Nottingham University Hospital - Wolfson Digestive Diseases Centre
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: European Society for Blood and Marrow Transplantation
ClinicalTrials.gov Identifier: NCT00297193    
Other Study ID Numbers: EudraCT2005-003337-40
ASTIC
First Posted: February 28, 2006    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: August 2013
Keywords provided by European Society for Blood and Marrow Transplantation:
Crohn's Disease
HSCT
Autologous
EBMT
ECCO
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases