A multicentre randomised interventional treatment trial of hematopoietic stem cell mobilisation followed by high dose immuno-ablation and autologous stem transplantation versus hematopoietic stem cell mobilisation only in Crohn's disease

European Group for Blood and Marrow Transplantation (EBMT) (UK)0 sites48 target enrollmentMay 21, 2010

ConditionsTopic: Oral and Gastrointestinal Subtopic: Oral and Gastrointestinal (all Subtopics)Disease: Gastrointestinal Digestive System Crohn's disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Topic: Oral and Gastrointestinal
Sponsor: European Group for Blood and Marrow Transplantation (EBMT) (UK)
Enrollment: 48
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 21, 2010

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

European Group for Blood and Marrow Transplantation (EBMT) (UK)

Eligibility Criteria

Inclusion Criteria

•1\. Aged between 18 and 50 years (patients aged 50 \- 65 years can participate if specially approved by the Trial Steering Committee)
•2\. Confirmed diagnosis of active Crohn's Disease:
•2\.1\. Diagnosis of Crohn's disease based on typical radiological appearances and/or typical histology
•2\.2\. Active disease at the time of registration to the trial, defined as Crohn's Disease Activity Index (CDAI) greater than or equal to 250 at any time within 3 months prior to trial entry, and greater than two of the following:
•2\.2\.1\. Raised C\-reactive protein (CRP)
•2\.2\.2\. Endoscopic evidence of active disease confirmed on histology
•2\.2\.3\. Clear evidence of active small bowel Crohn's disease on small bowel barium study
•3\. Unsatisfactory course despite three immunosuppressive agents (usually azathioprine, methotrexate and infliximab) in addition to corticosteroids. Patients should have relapsing disease (i.e. greater than or equal to 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:
•4\.1\. Inflammatory Bowel Disease Questionnaire (IBDQ)

Exclusion Criteria

•1\. Pregnancy or unwillingness to use adequate contraception during the study, if a woman of childbearing age
•2\. Concomitant severe disease:
•2\.1\. Renal: creatinine clearance less than 40 ml/min (measured or estimated)
•2\.2\. Cardiac: clinical evidence of refractory congestive heart failure; left ventricular ejection fraction less than 45% by multigated radionuclide angiography (MUGA) or cardiac echo; chronic atrial fibrillation necessitating oral anticoagulation; uncontrolled ventricular arrhythmia; pericardial effusion with hemodynamic consequences as evaluated by an experienced echo cardiographer
•2\.3\. Psychiatric disorders including active drug or alcohol abuse
•2\.4\. Concurrent neoplasms or myelodysplasia
•2\.5\. Bone marrow insufficiency defined as leucocytopaenia less than 3\.0 x 10^9/l, thrombocytopenia less than 50 x 10^9/l, anaemia less than 8 g/dl, CD4\+ T lymphopenia less than 200 x 10^6/l
•2\.6\. Uncontrolled hypertension, defined as resting systolic blood pressure greater than or equal to 140 ml and/or resting diastolic pressure greater than or equal to 90 ml mercury despite at least two anti\-hypertensive agents
•2\.7\. Uncontrolled acute or chronic infection with human immunodeficiency virus (HIV), Human T\-lymphotropic virus (HTLV) \- 1 or 2, hepatitis viruses or any other infection the investigator or Steering Committee consider a contraindication to participation
•2\.8\. Other chronic disease causing significant organ failure, including established cirrhosis with evidence of impaired synthetic function on biochemical testing and known respiratory disease causing resting arterial oxygen tension less than 8 kpa or carbon dioxide tension greater than 6\.7 kpa. Patients not known to have respiratory disease need not have blood gas measurements.