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Corticosteroid
Steroid Tapering for Pediatric Graft-versus-Host Disease
Phase 2
Recruiting
Led By Muna Qayed, MD, MS
Research Sponsored by John Levine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ann Arbor 1 GVHD by biomarkers
Performance score (Lansky/Karnofsky) ≥70%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing a blood test to help predict which kids with GVHD will respond well to steroids, so that they can be tapered off quickly.
Who is the study for?
This trial is for children and young adults (0-21 years) with a specific immune reaction called GVHD after bone marrow transplant. They must have certain biomarkers, not been treated with systemic steroids for GVHD before, and be in good physical condition. Pregnant individuals or those with severe liver disease, uncontrolled infections, or serious organ dysfunction cannot participate.Check my eligibility
What is being tested?
The trial tests if tapering steroid medication quickly can effectively treat GVHD in patients who are likely to respond well based on their biomarker levels. It aims to reduce the duration of high-dose steroid treatment to minimize side effects while monitoring symptoms and quality of life.See study design
What are the potential side effects?
Steroid treatments like prednisone may cause infections, high blood sugar, high blood pressure, muscle weakness, mood changes including depression and anxiety, sleep issues in the short term; long-term effects include bone damage, eye cataracts and stunted growth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is diagnosed with Grade 1 GVHD based on biomarkers.
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I am mostly active and can care for myself.
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I am 21 years old or younger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of CR, VGPR, or PR on day 28 with low cumulative steroid exposure
Secondary outcome measures
Cumulative incidence of Non-Relapse Mortality (NRM) at 12 months
Cumulative incidence of Non-Relapse Mortality (NRM) at 6 months
Graft-vs-Host Disease
+8 moreSide effects data
From 2016 Phase 3 trial • 854 Patients • NCT0000338998%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Hypoglycemia
8%
Dysphagia-esophageal radiation
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Steroid TaperExperimental Treatment1 Intervention
All enrolled patients start on the same dose of steroids for treatment of GVHD, blood samples are taken at week 1 and 2 post study start and biomarkers plus clinical response determines how steroid treatment is continued
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
John LevineLead Sponsor
3 Previous Clinical Trials
176 Total Patients Enrolled
Muna Qayed, MD, MSPrincipal InvestigatorChildren's Healthcare of Atlanta, Emory University School of Medicine
John E Levine, MD, MSPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is diagnosed with Grade 1 GVHD based on biomarkers.I have been newly diagnosed with GVHD, but it's not just a skin rash or only in my upper GI tract.My liver is not functioning well, shown by high bilirubin or liver enzyme levels.I am mostly active and can care for myself.I do not have an infection that is getting worse despite treatment.I am 21 years old or younger.My cancer is getting worse or not improving, needing a change in my immune therapy.I do not need dialysis, mechanical breathing support, or high oxygen.I have symptoms similar to chronic GVHD or overlap syndrome at enrollment.My treatment plan accepts any donor type and HLA match.My kidney function is low, with a filtration rate under 30 ml/min.I have GVHD but haven't had systemic treatment for it.I have not taken high doses of steroids for conditions other than adrenal issues, premeds, or symptom control in the last week.I have been treated for GVHD with steroids for more than 3 days before joining.
Research Study Groups:
This trial has the following groups:- Group 1: Steroid Taper
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.
In what ways is Prednisone regularly employed for therapeutic purposes?
"Prednisone can be used as a therapeutic medication for thyroiditis, ulcerative colitis, and malignant neoplasms."
Answered by AI
What is the aggregate amount of participants for this trial?
"Confirmative, the clinical trial is still open for recruitment. As per information on clinicaltrials.gov, this study was originally posted on September 1st 2022 and has been updated most recently on August 23rd of the same year. The research team requires 50 individuals to be recruited from 7 distinct locations across America."
Answered by AI
Is enrollment to this experiment still open?
"The clinical trial is still recruiting, as evidenced by the data on clinicaltrials.gov which was first published September 1st 2022 and updated August 23rd 2022."
Answered by AI
Has Prednisone been validated by the United States Food and Drug Administration?
"Prednisone has been assessed as a 2 on our scale of 1-3 due to the lack of efficacy data for this Phase 2 trial, yet there still exists some evidence indicating its safety."
Answered by AI
How many regional facilities are providing access to this research?
"Currently, the clinical trial is being carried out in 7 locations across America; Atlanta, New york and Philadelphia are among them. It may be wise to choose one of these centres nearby so as to limit travel when participating in this research."
Answered by AI
To what extent has Prednisone been utilized in other clinical investigations?
"As of now, there are 334 ongoing medical studies studying Prednisone with 92 trials in Phase 3. Although a few investigations regarding the drug have been conducted in Duarte, California, this medication is being studied at 16403 different sites globally."
Answered by AI
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