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Stem Cell Transplant Agent
Vedolizumab Post-Stem Cell Transplant for Crohn's Disease
Phase 2
Recruiting
Led By Amir Steinberg, MD
Research Sponsored by Aaron Etra
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No surgical therapeutic option secondary to risk of short bowel syndrome or patient refusal
Diagnosis of Crohn's disease by standard criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 1 year post transplant
Awards & highlights
Study Summary
This trial is testing whether the drug Vedolizumab can help improve remission for Crohn's Disease patients who have had a hematopoietic stem cell transplant.
Who is the study for?
This trial is for adults with active Crohn's Disease who haven't responded to standard treatments like corticosteroids, immunosuppressants, or biologics. They should not have heart, lung issues (like needing extra oxygen), HIV, a history of bad reactions to the trial drugs, be pregnant/breastfeeding, or too sick to do daily activities.Check my eligibility
What is being tested?
The study tests if combining an autologous stem cell transplant with drugs like Thymoglobulin and Cyclophosphamide followed by Vedolizumab can help achieve and maintain remission in Crohn's Disease. It involves hospital stays for chemotherapy and monitoring after the transplant.See study design
What are the potential side effects?
Possible side effects include reactions to medication infusions, increased risk of infections due to immune suppression from chemotherapy and stem cell transplant procedures. There may also be general side effects from high-dose steroids like Methylprednisolone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot have surgery due to the risk of severe digestive issues or because I chose not to.
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I have been diagnosed with Crohn's disease.
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My bowel disease is active, as confirmed by a specific test.
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My Crohn's disease is active, with a CDAI score over 250.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 1 year post transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 1 year post transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Crohn's Disease Activity Index (CDAI)
Secondary outcome measures
Change in endoscopic activity indices
Other outcome measures
Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
Change in burden of intestinal disease
Trial Design
1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment5 Interventions
Hematopoietic Stem Cell Transplant followed by maintenance Vedolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antithymocyte immunoglobulin (rabbit)
FDA approved
Cyclophosphamide
FDA approved
Vedolizumab
FDA approved
Autologous stem cell transplant
2010
Completed Phase 2
~130
Methylprednisolone
FDA approved
Find a Location
Who is running the clinical trial?
Aaron EtraLead Sponsor
Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,426 Total Patients Enrolled
Amir Steinberg, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have surgery due to the risk of severe digestive issues or because I chose not to.I have an infection that hasn't improved after a month of treatment.My heart's pumping ability is very weak or I need extra oxygen all the time.My lung function is severely reduced or I need extra oxygen.I have been diagnosed with Crohn's disease.My bowel disease is active, as confirmed by a specific test.I have not improved or can't take certain medications for my condition as determined by my gastroenterologist.I need assistance with my daily activities.My Crohn's disease is active, with a CDAI score over 250.I have heart problems that are not well-managed.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 50 Other Conditions - This treatment demonstrated efficacy for 50 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary reason that people use Experimental?
"leukemia, ophthalmia, sympathetic, and scalp structure are all responsive to Experimental treatment."
Answered by AI
Are volunteers being accepted for this clinical trial at this time?
"The study is currently recruiting participants, according to the information available on clinicaltrials.gov. The listing for the study was first posted on July 12, 2017 and was last updated on October 5, 2022."
Answered by AI
Has there been previous research on this topic?
"At present, there are 1003 ongoing trials for experimental treatments. 194 of those are in Phase 3. Although many studies for experimental treatments are based in Philadelphia, Pennsylvania, there are 32518 locations running such trials."
Answered by AI
Could you give me an estimate of how many individuals are enrolled in this clinical trial?
"That is correct. The information available on clinicaltrials.gov reveals that this trial was posted on 7/12/2017 and is looking for 50 participants at 1 locations."
Answered by AI
Is there a large body of evidence to support the use of this medication?
"While there is some evidence that the experimental medication is safe, it does not yet have any data supporting efficacy. Therefore, it received a score of 2."
Answered by AI
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