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Corticosteroid

Steroid Tapering for Pediatric Graft-versus-Host Disease

Phase 2
Recruiting
Led By John E Levine, 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%
Must not have
Significant liver disease evidenced by direct bilirubin >2 mg/dl or ALT or AST >5 times the upper limit of normal
Patients with uncontrolled infection (i.e., progressive symptoms related to infection despite treatment, persistently positive microbiological cultures despite treatment, viral reactivations unresponsive to treatment, or any other evidence of severe infection)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver is not functioning well, shown by high bilirubin or liver enzyme levels.
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I do not have an infection that is getting worse despite treatment.
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My cancer is getting worse or not improving, needing a change in my immune therapy.
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I do not need dialysis, mechanical breathing support, or high oxygen.
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I have symptoms similar to chronic GVHD or overlap syndrome at enrollment.
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My kidney function is low, with a filtration rate under 30 ml/min.
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I have been treated for GVHD with steroids for more than 3 days before joining.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of CR, VGPR, or PR on day 28 with low cumulative steroid exposure
Secondary study objectives
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 more

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
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%
Dysphagia-esophageal radiation
8%
Hypoglycemia
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
~2500

Find a Location

Who is running the clinical trial?

John LevineLead Sponsor
3 Previous Clinical Trials
176 Total Patients Enrolled
John E Levine, MD, MSPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Muna Qayed, MD, MSPrincipal InvestigatorChildren's Healthcare of Atlanta, Emory University School of Medicine

Media Library

Prednisone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05090384 — Phase 2
Graft-versus-Host Disease Research Study Groups: Steroid Taper
Graft-versus-Host Disease Clinical Trial 2023: Prednisone Highlights & Side Effects. Trial Name: NCT05090384 — Phase 2
Prednisone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05090384 — Phase 2
~9 spots leftby Mar 2025
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