High-dose Cyclophosphamide for Severe Refractory Crohn Disease
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|ClinicalTrials.gov Identifier: NCT01836289|
Recruitment Status : Withdrawn (Too difficult to recruit given new Crohn's medications approved)
First Posted : April 19, 2013
Last Update Posted : August 13, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease Crohn Disease||Drug: High-dose Cyclophosphamide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||High-dose Cyclophosphamide for Severe Refractory Crohn Disease|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
Experimental: High-dose Cyclophosphamide
Drug: High-dose Cyclophosphamide
- Evaluation of safety of the High-Dose Cyclophosphamide (HDC) protocol [ Time Frame: 3 Years ]Tablulation of serious adverse events associate with the HDC protocol
- HDC-Induced Steroid-free remission [ Time Frame: 3 Years ]To determine if HDC therapy can induce and maintain a steroid-free clinical remission (defined as CDAI<150) at 12 and 52 weeks. Applies to patients without an existing ostomy.
- HDC-Induced Mucosal Healing [ Time Frame: 3 Years ]To determine if HDC therapy can induce sustained mucosal healing defined as absence of ulcers on colonoscopy
- Improvement in patient reported quality of life [ Time Frame: 3 years ]To determine if HDC can lead to improvement in inflammatory bowel disease questionnaire scores at weeks 12 and 52
- Molecular Mechanisms of High-dose Cyclophosphamide (HiCy) Therapy [ Time Frame: 3 Years ]To investigate the molecular mechanisms by which HiCy therapy works by analyzing the effects of HiCy on the levels of serum cytokines (using multiplex ELISA), and correlate the data with clinical activity and treatment response.
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): NCT01836289
|Principal Investigator:||Mark G. Lazarev, MD||Johns Hopkins University|