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Combination Therapy for Graft-versus-Host Disease
Study Summary
This trial is studying a novel combination of drugs to find the lowest possible dose of corticosteroids required to treat high-risk aGVHD while still being effective.
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.Side effects data
From 2018 Phase 4 trial • 2037 Patients • NCT01950819Trial Design
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Who is running the clinical trial?
Media Library
- I am over 12 and starting treatment for severe aGVHD within 7 days.I cannot or will not stop taking hormone therapy for cancer.I cannot or will not stop taking supplemental sex hormones.My kidney function, measured by creatinine, is within the normal range.I have been newly diagnosed with high-risk acute graft-versus-host disease.I do not have any untreated serious infections.I am on full-dose anticoagulants for a blood clot condition.I am not willing to use birth control during and for 30 days after treatment.I have had cancer that responded to hormone therapy.My heart's pumping ability is at least 35%.I have aGVHD with high amphiregulin levels according to the UMN test.I have aGVHD and my risk level is confirmed by a specific test.My cancer is getting worse.I have had a blood clot in the past 3 months.
- Group 1: Ruxolitinib;hCG (Pregnyl®) ;Corticosteroids
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 other documented experiments of Corticosteroids?
"Presently, 500 trials are underway researching Corticosteroids with 123 of these being in Phase 3. Although the majority of studies involving this treatment originate from Duarte, California there is still a wide geographical spread as it has been observed at 20425 sites globally."
How many individuals have been registered to participate in this investigation?
"The recruitment period for this study has ended. Initially posted on March 1st, 2023 and last updated November 2nd 2022, no more patients are being accepted into the trial. However, there are 171 studies actively accepting candidates with graft-vs-host disease and 500 clinical trials offering Corticosteroids to new participants."
Have enrollment opportunities for this investigation opened yet?
"According to the details available on clinicaltrials.gov, this particular trial is no longer looking for participants; it was initially posted in March of 2023 and last updated in November 2022. However, 671 other medical studies are still recruiting at this time."
What conditions are typically addressed with Corticosteroids?
"Corticosteroids are typically prescribed to treat scalp structure, however they can also be beneficial for those suffering from thyroiditis, ulcerative colitis or varicella-zoster virus acute retinal necrosis."
What can participants anticipate as the ultimate outcome of this clinical trial?
"This clinical trial will run for 28 days, with the primary goal of determining a safe and effective dose of corticosteroids when combined with ruxolitinib and uhCG/EGF in pediatric patients. Secondary objectives include collecting blood samples and rectosigmoid biopsies to facilitate future correlative studies; comparing rate of treatment failure from this protocol against historical control data; and assessing patient quality-of-life on study through an overall survival survey."
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