Acute Graft-versus-host DiseasePhase 2MAGIC VNCT06936566
MAGIC Ruxolitinib for aGVHD
A Phase 2 study testing Ruxolitinib and Methylprednisolone in people with Acute Graft-versus-host Disease and Allogeneic Bone Marrow Transplantation, run by John Levine at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Graft-versus-host Disease, Allogeneic Bone Marrow Transplantation, Adverse Effects
- What is being tested?
- Ruxolitinib and Methylprednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 14 sitesUnited States
- Study dates
- 14 May 2025to 14 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Standard risk cohort: Minnesota standard risk GVHD (except patients with grade I [<50% BSA rash])
- High risk cohort: Minnesota high risk GVHD 3 GVHD that developed after DLI for mixed chimerism or poor graft function is allowed
- No prior systemic acute GVHD treatment. Topical or non-absorbed steroids are permitted.
- All donor types, HLA-matches, conditioning regimens, or GVHD prophylaxis strategies are acceptable
- ≥18 years of age
- Standard risk cohort: Hematopoietic engraftment with absolute neutrophil count (ANC) ≥ 1000/μL and platelet count ≥20,000. Use of growth factor supplementation and transfusions to maintain adequate hematologic parameters are allowed.
- High risk cohort: Hematopoietic engraftment with ANC ≥ 500/uL and platelet count ≥20,000. Use of growth factor supplementation and transfusions to maintain adequate hematologic parameters are allowed.
Who cannot join
- Systemic treatment with ruxolitinib or any other JAK inhibitor within 7 days of study entry
- Prior use of ruxolitinib to treat GVHD at any time
- Relapsed, progressing or persistent malignancy requiring withdrawal of systemic immunosuppression
- Relapse prior to development of GVHD unless subsequently in remission for at least 3 months
- GVHD that developed after DLI for relapse is not allowed without study PI or medical monitor approval
- Uncontrolled infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)
Show all 12Show fewer
- Severe organ dysfunction within 3 days of enrollment including requirement for dialysis, mechanical ventilation, continuous BiPAP, or continuous high flow oxygen by nasal cannula, or total bilirubin ≥ 3x upper limit of normal not due to GVHD.
- A clinical presentation resembling de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment (except for mild oral or ocular GVHD)
- Corticosteroids >10 mg/day methylprednisolone (or other methylprednisolone equivalent, MPE) for any indication within 5 days before the onset of acute GVHD except for adrenal insufficiency or premedication for transfusions/IV meds
- Participation in clinical trials using experimental agents not approved by the FDA for any indication within 14 days of enrollment or five half-lives, whichever is longer provided any prior adverse events have improved to ≤grade 1
- Patients who are pregnant or nursing
- History of allergic reaction to ruxolitinib or any JAK inhibitor
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Amelia Langston, MD, 404-441-7572, alangst@emory.edu
Amelia Langston
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Zachariah DeFilipp, MD, 617-726-5743, zdefilipp@mgh.harvard.edu
Zachariah DeFilipp
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Corey Cutler, MD, MPH, 617-632-5946, corey_cutler@dfci.harvard.edu
Corey Cutler
- Not yet recruiting
Ohio State University
Columbus, Ohio, 43210
Hannah Choe, MD, 614-293-1396, Hannah.Choe@osumc.edu
Hannah Choe
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Monzr Al Malki, MD, 626-256-4673, malmalki@coh.org
Monzr Al Malki
- Recruiting
Kansas University Medical Center
Fairway, Kansas, 66205
Umair Mushtaq, MD, 913-945-5793, mmushtaq@kumc.edu
Umair Mushtaq, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Amin Alousi, MD, 713-745-8613, aalousi@mdanderson.org
Amin Alousi
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37235
Carrie Kitko, DM, 615-936-2088, carrie.l.kitko@vumc.org
Carrie Kitko, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
John Levine, MD, MS, 212-241-1469, john.levine@mssm.edu
John Levine
- Not yet recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Elizabeth Hexner, MD, 215-614-1847
Elizabeth Hexner, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
William Hogan, MB, ChB, 507-284-2176, hogan.william@mayo.edu
William Hogan
- Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Marco Mielcarek, MD, 206-667-2827, mmielcar@fredhutch.org
Marco Mielcarek
- Not yet recruiting
Washington University
St Louis, Missouri, 63110
Iskra Pusic, MD, MSCI, 314-747-8465, iskrapusic@wustl.edu
Iskra Pusic
- Not yet recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Joseph Pidala, MD, PhD, 813-745-2556, joseph.pidala@moffitt.org
Joseph Pidala
About this study
Official title: Phase 2 Study of Ruxolitinib-Based Primary Treatment for Acute GVHD
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.
- Being tested
- Ruxolitinib, Methylprednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called Jakafi
Ruxolitinib twice daily for 56 days followed by a short taper Given orally
Also called Depo-Medrol, Medrol, Solu-Medrol
Starting dose 2 mg/kg/d for at least three days, then taper Given IV or orally
| Study group | Role | What they receive |
|---|---|---|
| Minnesota Standard Risk lower dose | Experimental | Patients receive lower dose ruxolitinib orally (PO) twice daily (BID) for 56 days then begin taper PO once daily (QD) for 1 week in the absence of disease progression or unacceptable toxicity Receives: Drug: Ruxolitinib |
| Minnesota Standard Risk higher dose | Experimental | Patients receive higher dose ruxolitinib PO BID for 56 days then begin taper PO BID for 1 week, followed by PO QD for 1 week in the absence of disease progression or unacceptable toxicity. Receives: Drug: Ruxolitinib |
| Minnesota High Risk | Experimental | Patients receive higher dose ruxolitinib PO BID for 56 days then begin taper PO BID for 1 week, followed by PO QD for 1 week in the absence of disease progression or unacceptable toxicity. Patients also receive systemic corticosteroid (methylprednisolone or similar) for a minimum of 3 days, then taper dose every 3-5 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Ruxolitinib; Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 28 Treatment Response
Day 28 response to treatment defined as complete (CR), very good partial (VGPR), or partial (PR) response without intervening therapy or death to ruxolitinib monotherapy.
CR - All evaluable organs (skin, liver, GI tract) stage 0. For a response to be scored as CR, the patient must be in CR on the date of assessment and have had no intervening additional GVHD therapy.
VGPR - Stage 0 liver and GI and residual stage 1 skin GVHD. For a response to be scored as VGPR, the patient must be in VGPR on the date of assessment and have had no intervening additional GVHD therapy.
PR - An improvement by one or more stages in one or more organ involved with GVHD symptoms without worsening in others. For a response to be scored as PR, the patient must be in PR on the date of assessment and have had no intervening additional GVHD therapy.
Measured: 28 days
Secondary outcomes (8)
Steroid-refractory GVHD
Steroid Refractory (SR) GVHD is defined as GVHD that either does not achieve a clinical response or an additional line of therapy is initiated by day 28 from the initiation of systemic steroid therapy for non-responsive GVHD.
Measured: 28 days
Durable response at day 56
Durable response at day 56 is defined as CR, VGPR, or PR by day 28 and no GVHD flare, intervening treatment or death by day 56
Measured: 56 days
GVHD flares
Flare is defined as an increase in acute GVHD severity in at least one target organ by at least one stage that is treated with an additional line of treatment or an increase in steroid dose in methylprednisolone equivalents (MPE) by at least 25%
Measured: 90 days
Cumulative systemic corticosteroid dose
Measured: 90 days
Chronic GVHD requiring systemic steroid treatment
Measured: 1 year
Overall survival
OS (overall survival) - defined as the time from the enrollment to death
Measured: 1 year
Non-relapse mortality
Non-relapse mortality (NRM) - defined as any death that occurs after HCT not attributable to relapse of the underlying disease for transplant
Measured: 1 year
Relapse
Relapse - defined as reoccurrence of the underlying disease for transplant
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start14 May 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion14 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft-versus-host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Levine
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation, National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, John Levine, Icahn School of Medicine at Mount Sinai
- Investigators
- John Levine, MD, MS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936566
- Sponsor's protocol ID
- STUDY-24-01656
- Other IDs
- P01CA039542
- Acronym
- MAGIC V
- Status last verified
- Mar 2026
- First submitted
- 12 Apr 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Patient did not consent to this
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Ruxolitinib-Based Primary Treatment for Acute GVHD
- ClinicalTrials.gov ID
- NCT06936566
- Acronym / sponsor ID
- MAGIC V / STUDY-24-01656
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- John LevineUniversity, hospital or other
- Collaborators
- Incyte Corporation, National Cancer Institute (NCI)
- Study start
- 14 May 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 14 Apr 2028 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Minnesota Standard Risk lower dose | Experimental | Drug: RuxolitinibPatients receive lower dose ruxolitinib orally (PO) twice daily (BID) for 56 days then begin taper PO once daily (QD) for 1 week in the absence of disease progression or unacceptable toxicity |
| Minnesota Standard Risk higher dose | Experimental | Drug: RuxolitinibPatients receive higher dose ruxolitinib PO BID for 56 days then begin taper PO BID for 1 week, followed by PO QD for 1 week in the absence of disease progression or unacceptable toxicity. |
| Minnesota High Risk | Experimental | Drug: Ruxolitinib, Drug: MethylprednisolonePatients receive higher dose ruxolitinib PO BID for 56 days then begin taper PO BID for 1 week, followed by PO QD for 1 week in the absence of disease progression or unacceptable toxicity. Patients also receive systemic corticosteroid (methylprednisolone or similar) for a minimum of 3 days, then taper dose every 3-5 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Standard risk cohort: Minnesota standard risk GVHD (except patients with grade I [<50% BSA rash])
- High risk cohort: Minnesota high risk GVHD 3 GVHD that developed after DLI for mixed chimerism or poor graft function is allowed
- No prior systemic acute GVHD treatment. Topical or non-absorbed steroids are permitted.
- All donor types, HLA-matches, conditioning regimens, or GVHD prophylaxis strategies are acceptable
- ≥18 years of age
Key exclusion criteria (12 listed)
- Systemic treatment with ruxolitinib or any other JAK inhibitor within 7 days of study entry
- Prior use of ruxolitinib to treat GVHD at any time
- Relapsed, progressing or persistent malignancy requiring withdrawal of systemic immunosuppression
- Relapse prior to development of GVHD unless subsequently in remission for at least 3 months
- GVHD that developed after DLI for relapse is not allowed without study PI or medical monitor approval
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolitinibAlso: JakafiRuxolitinib twice daily for 56 days followed by a short taper Given orally | Drug | Minnesota High Risk, Minnesota Standard Risk higher dose, Minnesota Standard Risk lower dose |
| MethylprednisoloneAlso: Depo-Medrol, Medrol, Solu-MedrolStarting dose 2 mg/kg/d for at least three days, then taper Given IV or orally | Drug | Minnesota High Risk |
Primary outcome
Day 28 Treatment Response
Time frame: 28 days
Day 28 response to treatment defined as complete (CR), very good partial (VGPR), or partial (PR) response without intervening therapy or death to ruxolitinib monotherapy. CR - All evaluable organs (skin, liver, GI tract) stage 0. For a response to be scored as CR, the patient must be in CR on the date of assessment and have had no intervening additional GVHD therapy. VGPR - Stage 0 liver and GI and residual stage 1 skin GVHD. For a response to be scored as VGPR, the patient must be in VGPR on the date of assessment and have had no intervening additional GVHD therapy. PR - An improvement by one or more stages in one or more organ involved with GVHD symptoms without worsening in others. For a response to be scored as PR, the patient must be in PR on the date of assessment and have had no intervening additional GVHD therapy.
8 secondary outcomes
Steroid-refractory GVHD
Time frame: 28 days
Durable response at day 56
Time frame: 56 days
GVHD flares
Time frame: 90 days
Cumulative systemic corticosteroid dose
Time frame: 90 days
Chronic GVHD requiring systemic steroid treatment
Time frame: 1 year
Overall survival
Time frame: 1 year
Non-relapse mortality
Time frame: 1 year
Relapse
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No. Patient did not consent to this
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Levine, MD, MS principal investigator
Icahn School of Medicine at Mount Sinai
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruxolitinib and Methylprednisolone in people with Acute Graft-versus-host Disease and Allogeneic Bone Marrow Transplantation, run by John Levine at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Young, BA (646-937-1246, rachel.young@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 28 Treatment Response (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.