High-dose Cyclophosphamide for Severe Refractory Crohn Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01836289
• Date of registration: 17/04/2013
• Prospective Registration: Yes
• Primary sponsor: Johns Hopkins University
• Public title: High-dose Cyclophosphamide for Severe Refractory Crohn Disease
• Scientific title: High-dose Cyclophosphamide for Severe Refractory Crohn Disease
• Date of first enrolment: March 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01836289
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Mark G. Lazarev, MD
• Affiliation: Johns Hopkins University

Key inclusion & exclusion criteria

Inclusion Criteria:

- = 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Crohn's Disease

Intervention(s)

Drug: High-dose Cyclophosphamide

Primary Outcome(s)

Evaluation of safety of the High-Dose Cyclophosphamide (HDC) protocol [Time Frame: 3 Years]

Secondary Outcome(s)

HDC-Induced Steroid-free remission [Time Frame: 3 Years]

Improvement in patient reported quality of life [Time Frame: 3 years]

Molecular Mechanisms of High-dose Cyclophosphamide (HiCy) Therapy [Time Frame: 3 Years]

HDC-Induced Mucosal Healing [Time Frame: 3 Years]

Secondary ID(s)

NA_00052668

Source(s) of Monetary Support

Please refer to primary and secondary sponsors