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Corticosteroid
Combination Therapy for Graft-versus-Host Disease
Phase 1 & 2
Recruiting
Led By Sherman Holtan, MD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HCT recipients over 12 years of age within the first 7 days of initial treatment of high-risk aGVHD, defined as:
Renal: Serum creatinine ≤2.5x upper limit of normal (ULN)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post treatment
Awards & highlights
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.
Who is the study for?
This trial is for HCT recipients over 12 years old with high-risk aGVHD, or standard risk aGVHD plus certain biomarkers. Participants need functioning kidneys and hearts, and must consent to the study. Excluded are those with current severe infections, hormone-responsive cancers, thrombosis, or unwilling to stop hormone therapies or avoid pregnancy.Check my eligibility
What is being tested?
The study tests the lowest effective dose of corticosteroids combined with ruxolitinib and uhCG/EGF for treating high-risk acute Graft-versus-Host Disease (aGVHD). It's a single-arm phase I/II trial aiming to find this dose without affecting response rates at day 28.See study design
What are the potential side effects?
Potential side effects include immune system suppression leading to increased infection risk, blood sugar increases from steroids, hormonal changes due to hCG/EGF therapy, and possible liver function alterations from ruxolitinib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 12 and starting treatment for severe aGVHD within 7 days.
Select...
My kidney function, measured by creatinine, is within the normal range.
Select...
I have been newly diagnosed with high-risk acute graft-versus-host disease.
Select...
My heart's pumping ability is at least 35%.
Select...
I have aGVHD with high amphiregulin levels according to the UMN test.
Select...
I have aGVHD and my risk level is confirmed by a specific test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best response of treatment in adult and children
Recommend the lowest possible dose for Phase II of corticosteroids when given in combination with ruxolitinib and uhCG/EGF in pediatric based on DLT frequency
Secondary outcome measures
Collect blood samples and rectosigmoid biopsies for future correlative studies
Compare the rate of treatment failure for acute GVHD after initiation of protocol therapy to historical controls
Determine 1-year overall survival
+4 moreSide effects data
From 2018 Phase 4 trial • 2037 Patients • NCT0195081934%
Oedema peripheral
24%
Constipation
24%
Diarrhoea
24%
Hypertension
22%
Anaemia
22%
Urinary tract infection
19%
Hypophosphataemia
19%
Nausea
16%
Hyperkalaemia
15%
Hypokalaemia
14%
Hyperglycaemia
14%
Blood creatinine increased
13%
Diabetes mellitus
13%
Hyperlipidaemia
13%
Headache
13%
Hypomagnesaemia
13%
Proteinuria
12%
Vomiting
11%
Nasopharyngitis
11%
Hypocalcaemia
11%
Pyrexia
10%
Tremor
10%
Dyslipidaemia
10%
Hypercholesterolaemia
10%
Haematuria
10%
Insomnia
9%
Leukopenia
9%
Back pain
9%
Procedural pain
9%
Abdominal pain
8%
Metabolic acidosis
8%
Cough
8%
Upper respiratory tract infection
7%
Thrombocytopenia
7%
Dyspnoea
7%
Pain in extremity
6%
BK virus infection
6%
Complications of transplanted kidney
6%
Hypertriglyceridaemia
6%
Acne
6%
Arthralgia
6%
Dysuria
6%
Fatigue
6%
Hypotension
5%
Vitamin D deficiency
5%
Pneumonia
5%
Acute kidney injury
5%
Polycythaemia
5%
Tachycardia
5%
Hyperuricaemia
5%
Incision site pain
5%
Dizziness
5%
Anxiety
4%
Transplant rejection
4%
Abdominal pain upper
4%
Weight increased
4%
Hypercalcaemia
3%
Alopecia
3%
Lymphocele
2%
Kidney transplant rejection
2%
Gastroenteritis
2%
Pyelonephritis
2%
Sepsis
2%
Pulmonary embolism
2%
Cytomegalovirus infection
2%
Renal impairment
2%
Graft loss
2%
Deep vein thrombosis
2%
Leukocytosis
2%
Urosepsis
1%
Angina pectoris
1%
Cardiac failure congestive
1%
Impaired healing
1%
Pneumocystis jirovecii pneumonia
1%
Pyelonephritis acute
1%
Septic shock
1%
Delayed graft function
1%
Incisional hernia
1%
Transplant dysfunction
1%
Dehydration
1%
Osteonecrosis
1%
Squamous cell carcinoma
1%
Hydronephrosis
1%
Urinary incontinence
1%
Influenza
1%
Basal cell carcinoma
1%
Thrombotic microangiopathy
1%
Wound dehiscence
1%
Acute myocardial infarction
1%
Atrial fibrillation
1%
Cardiac failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Everolimus Plus@Reduced CNI
MPA Plus Standard@CNI
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ruxolitinib;hCG (Pregnyl®) ;CorticosteroidsExperimental Treatment3 Interventions
Ruxolitinib 10 mg by mouth twice daily (with dose adjustments as indicated) through day 56, followed by taper
hCG (Pregnyl®) 2,000 units/m2 SQ every other day x 3 doses, followed by twice weekly x 14 doses (total 17 doses through day 56)
Corticosteroids (Prednisone, or IV methylprednisolone equivalent)
Dose level 1 (starting dose) = 1 mg/kg
Dose level 2 = 0.5 mg/kg
Dose level 3 = 0.25 mg/kg
Dose level 4 = 0.1 mg/kg
Dose level 5 = 0 mg/kg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Corticosteroids
2003
Completed Phase 4
~8270
hCG
2013
Completed Phase 4
~4010
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
272 Previous Clinical Trials
14,598 Total Patients Enrolled
Sherman Holtan, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
1 Previous Clinical Trials
75 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Ruxolitinib;hCG (Pregnyl®) ;Corticosteroids
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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