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NCT06936566 · ClinicalTrials.gov registry record · Phase 2
MAGIC Ruxolitinib for aGVHD
A Phase 2 study of Acute-graft-versus-host Disease and Adverse Effects, sponsored by John Levine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
- 14
- Study locations
NCT06936566 is a Phase 2 study of Acute-graft-versus-host Disease and Adverse Effects that is actively recruiting participants, run by John Levine. The registered enrollment target is 98 participants, roughly in line with the 94-participant average among 7 other Acute-graft-versus-host Disease trials with a reported enrollment target. The trial reports 14 study locations across 13 states.
The verdict
NCT06936566, a Phase 2 study of Acute-graft-versus-host Disease and Adverse Effects, is actively recruiting participants, sponsored by John Levine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
- 14
- Study locations
Study Summary
This clinical trial will study ruxolitinib-based treatment of acute graft-versus-host-disease (GVHD) that developed following allogeneic hematopoietic cell transplant. Acute GVHD occurs when donor cells attack the healthy tissue of the body. The most common symptoms are skin rash, jaundice, nausea, vomiting, and/or diarrhea. The standard treatment for GVHD is high dose steroids such as prednisone or methylprednisolone, which suppresses the donor cells, but sometimes there can be either no response or the response does not last. In these cases, the GVHD can become dangerous or even life threatening. High dose steroid treatment can also cause serious complications. Researchers have developed a system, called the Minnesota risk system, to help predict how well the GVHD will respond to steroids based on the symptoms present at the time of diagnosis. The Minnesota risk system classifies patients with newly diagnosed acute GVHD into two groups with highly different responses to standard steroid treatment and long-term outcomes. This protocol maximizes efficiency because all patients with grade II-IV GVHD are eligible for screening and treatment is assigned according to patient risk. Patients with lower risk GVHD, Minnesota standard risk, have high response rates to steroid treatment. In this trial the researchers will test whether ruxolitinib alone is as effective (non-inferior) as steroid-free therapy and safe. Patients will be randomized to two different doses of ruxolitinib to identify the dose which maximizes efficacy while minimizing toxicities such as hematologic and infectious toxicities. Patients with higher risk GVHD, Minnesota high risk, have unacceptable outcomes with systemic corticosteroid treatment alone and the researchers will test whether adding ruxolitinib, a proven effective second line GVHD treatment, can improve outcomes when added to systemic corticosteroids as first line treatment.
Conditions Studied
Interventions
- DRUG Ruxolitinib
- DRUG Methylprednisolone
Study Locations (14)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
California
- City of Hope Comprehensive Cancer Center - Duarte
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Winship Cancer Institute, Emory University - Atlanta
Kansas
- Kansas University Medical Center - Fairway
Minnesota
- Mayo Clinic - Rochester
Missouri
- Washington University - St Louis
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2025-05-14 |
| Est. Completion | 2028-04-14 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06936566
The ClinicalTrials.gov registry entry for NCT06936566 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 94-participant average among 7 other Acute-graft-versus-host Disease trials with a reported enrollment target. The listed sponsor is John Levine, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Acute-graft-versus-host Disease appearing as the primary indexed condition, and to 2 interventions - of which Ruxolitinib is the first listed.
NCT06936566 reports 14 study locations spanning 13 distinct geographic areas - top geographies include Massachusetts, California, Florida.
Frequently Asked Questions
What is clinical trial NCT06936566 about?
NCT06936566 is a clinical study titled "MAGIC Ruxolitinib for aGVHD". This clinical trial will study ruxolitinib-based treatment of acute graft-versus-host-disease (GVHD) that developed following allogeneic hematopoietic cell transplant. Acute GVHD occurs when donor cells attack the healthy tissue of the body. The most common symptoms are skin rash, jaundice, nausea, ...
What is the current status of trial NCT06936566?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2025-05-14. Estimated completion is 2028-04-14.
What conditions does trial NCT06936566 study?
This clinical trial studies the following conditions: Acute-graft-versus-host Disease, Adverse Effects, Allogeneic Bone Marrow Transplantation.
What interventions are being tested in trial NCT06936566?
The interventions under investigation include: Ruxolitinib (DRUG), Methylprednisolone (DRUG).
Who is sponsoring clinical trial NCT06936566?
This trial is sponsored by John Levine, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06936566 being conducted?
This trial has 14 study locations across California, Florida, Georgia, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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