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New treatment option for Crohn Disease
Official title Autologous Stem Cell Transplant for Crohn's Disease
ClinicalTrials.gov ID: NCT03219359
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for crohn disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Crohn's Disease (CD) is an inflammatory bowel disease. It can lead to significant complications and discomfort in the stomach and intestines.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of Crohn's disease by standard criteria
- Active disease based on clinical symptoms, defined as CDAI \>250. In patients with an ostomy, the number of liquid stools score in the CDAI will be...
- Active disease based on endoscopic evaluation, defined as SES-CD score \> 3 in at least one bowel segment
- Failure to respond to (or intolerant/adverse reaction to or declines) a member of each of the class of drugs listed below:
- corticosteroids
You likely can't join if
- History of significant toxicity to any medications used in trial (cyclophosphamide, thymoglobulin, vedolizumab)
- Pregnant or breastfeeding
- Age \<18
- Karnofsky Performance Score \<60
- Patients who have an uncontrolled infection (presumed or documented) despite appropriate therapy for at least one month
- Patients with symptomatic coronary artery disease or uncontrolled congestive heart failure.
See the full eligibility criteria
- Diagnosis of Crohn's disease by standard criteria
- Active disease based on clinical symptoms, defined as CDAI \>250. In patients with an ostomy, the number of liquid stools score in the CDAI will be replaced by the number of times that the ostomy bag is emptied daily.
- Active disease based on endoscopic evaluation, defined as SES-CD score \> 3 in at least one bowel segment
- Failure to respond to (or intolerant/adverse reaction to or declines) a member of each of the class of drugs listed below:
- corticosteroids
- azathioprine,
- 6-mercaptopurine, methotrexate
- Anti-TNFα (infliximab, adalimumab, certolizumab, golimumab)
- Anti-integrin agents (natalizumab, vedolizumab)
- Ustekinumab
- Failure to respond refers to ongoing objective inflammation with symptoms and, as is traditional, is defined by the gastroenterologist evaluating the patient.
- No surgical therapeutic option secondary to risk of short bowel syndrome or patient refusal
- History of significant toxicity to any medications used in trial (cyclophosphamide, thymoglobulin, vedolizumab)
- Pregnant or breastfeeding
- Age \<18
- Karnofsky Performance Score \<60
- Patients who have an uncontrolled infection (presumed or documented) despite appropriate therapy for at least one month
- Patients with symptomatic coronary artery disease or uncontrolled congestive heart failure.
- HIV infected
- Ejection fraction \<30% or requiring supplemental continuous oxygen.
- DLCO \<35% or requiring supplementary oxygen.
- Patients for whom an insufficient number of stem cells (\<2 X 10\^6/kg) have been collected.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.