Status:
WITHDRAWN
High-dose Cyclophosphamide for Severe Refractory Crohn Disease
Lead Sponsor:
Johns Hopkins University
Conditions:
Crohn's Disease
Crohn Disease
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
PHASE2
Brief Summary
This research is being done to see if people with Crohn's disease who receive high-dose cyclophosphamide have an improvement of their disease, how long the benefit may last, and how safe cyclophospham...
Eligibility Criteria
Inclusion
- ≥ 18 years of age, males and females will be eligible
- Moderate to severe Crohn's Disease (CD) with CDAI \> 220, in addition to evidence of ulceration on ileocolonoscopy or active disease on small bowel imaging (in patients with an ostomy, CDAI criteria do not apply)
- Disease progression (primary or secondary non-responder, or reaction to) to at least one anti-tumor necrosis factor (TNF) agent (infliximab, adalimumab, certolizumab pegol), and additionally had disease progression despite one of the following immunosuppressant drugs: azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, natalizumab, vedolizumab
- Willingness to participate in a clinical trial
- Approval by Enrollment Panel, who will collectively decide on the appropriateness of possible study study participants
Exclusion
- Pregnant or nursing women
- Sexually active men and women who do not agree to use effective means of birth control during treatment period
- Evidence of primarily fibrostenosing disease without active inflammatory disease on disease staging
- Co-morbid conditions including cardiac disease with an ejection fraction of \< 45%, chronic renal failure with serum creatinine \> 2.0, liver disease with total bilirubin \> 2.0, (excluding hyperbilirubinemia secondary to Gilbert's disease) or transaminitis \> 3x upper limit of normal.
- History of serious allergic reaction to cyclophosphamide
- History of malignancy in the last 5 years (excluding non-melanomatous skin cancers)
- Patients who are pre-terminal
- Toxic megacolon
- Active infection
- White blood cell count \< 3000 cells/ul, platelets \< 100K / ul, hemoglobin \< 10.0 g/dL
- Any use of thiopurines, methotrexate or anti-TNF agents in the previous four weeks prior to treatment
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01836289
Start Date
March 1 2015
End Date
March 1 2018
Last Update
August 13 2018
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