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Itolizumab + Corticosteroids for Acute Graft-Versus-Host Disease
Study Summary
This trial is testing a new drug to see if it is better than placebo at treating aGVHD, a serious complication from stem cell transplants.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I am taking immunosuppressants other than corticosteroids for aGVHD.I had an emergency cell transplant due to cancer returning after a stem cell transplant.I have had a stem cell transplant from a donor.I am 12 years or older and weigh more than 40kg.My cancer has returned or is getting worse, except for skin cancer or early-stage breast cancer.I need treatment for remaining disease not specified before my stem cell transplant.I have chronic graft-versus-host disease or overlap syndrome.I haven't taken high doses of steroids for conditions other than aGVHD in the last week.I started corticosteroid treatment for aGVHD less than 3 days ago and will get a specific dose on Day 1.I have a severe form of acute graft-versus-host disease.
- Group 1: Itolizumab (EQ001)
- Group 2: EQ001 Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are there any current openings for participants in this trial?
"The study is still ongoing, as seen from the clinicaltrials.gov website. This experiment was first advertised on April 29th, 2022 and has had a recent update on October 28th, 2022."
In how many hospitals is this study being conducted?
"This trial is currently being conducted at 15 research institutions, including McGill University Health Center - Research Institute in Montréal, University of Alabama at Birmingham in Birmingham, Fred Hutchinson Cancer Research Center in Seattle, and 12 other locations."
How many people are participating in this research project?
"In order to move forward, this study requires the recruitment of 200 patients that meet specific inclusion criteria. The trial is being conducted at multiple locations, such as McGill University Health Center - Research Institute in Montréal, Quebec and University of Alabama at Birmingham in Birmingham, Alabama."
Are there any recorded allergic reactions to Itolizumab?
"There is evidence from prior clinical trials to support the safety of Itolizumab, so it received a score of 3."
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