High-dose Cyclophosphamide for Severe Refractory Crohn Disease
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crohn's Disease; Crohn Disease
Intervention: High-dose Cyclophosphamide (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s): Mark G. Lazarev, MD, Principal Investigator, Affiliation: Johns Hopkins University
Overall contact: Mark G. lazarev, MD, Phone: 410.502-3147, Email: mlazare1@jhmi.edu
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 cyclophosphamide is. This study is for patient with medically refractory disease
that is not easily amenable to surgery.
Cyclophosphamide is an FDA-approved chemotherapy medication that is also frequently used to
treat autoimmune illness; use of cyclophosphamide for autoimmune disease is not approved by
the FDA. An autoimmune illness is when the immune system mistakenly attacks self, targeting
the cells, tissues, and organs of a person's own body. There are many different autoimmune
diseases and they can each affect the body is different ways. Crohn's disease is an
autoimmune disease that primarily affects the small and large intestines. High
dose-cyclophosphamide has been successfully used to treat Crohn's, primarily as part of a
conditioning regimen for autologous stem cell transplantation. However, this therapy is
limited in Crohn's because of it's serious infectious risks. This current study involves
using high-dose cyclophosphamide without need for stem cell transplantation. This appears
to be a safer approach in other autoimmune illnesses that have been studied.
Clinical Details
Official title: High-dose Cyclophosphamide for Severe Refractory Crohn Disease
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Evaluation of safety of the High-Dose Cyclophosphamide (HDC) protocol
Secondary outcome: HDC-Induced Steroid-free remissionHDC-Induced Mucosal Healing Improvement in patient reported quality of life Molecular Mechanisms of High-dose Cyclophosphamide (HiCy) Therapy
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Mark G. lazarev, MD, Phone: 410.502-3147, Email: mlazare1@jhmi.edu
Johns Hopkins Medical Institutions, Baltimore, Maryland 21205, United States; Recruiting Mark G. lazarev, MD, Phone: 410-502-3147, Email: mlazare1@jhmi.edu
Additional Information
Starting date: March 2015
Last updated: March 1, 2015
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