A Phase 1 interventional study of Ruxolitinib and LBP- MARCO in Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD), sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment
Among 27 studies testing ruxolitinib in Graft vs Host Disease — 13 open to participants now, 16 under way, 2 of them phase 3. ruxolitinib · Graft vs Host Disease.
Among the 27 studies testing ruxolitinib in Graft vs Host Disease, this one is the 24th largest by planned enrollment, is one of 6 that started in 2026, is one of 3 in phase 1, reaches primary completion later than 9 of the 15 other live ones, and was the 27th registered.
804 studies on the registry are indexed under Graft vs Host Disease; 149 are open to participants now.
Browse Graft vs Host Disease studies →13 of the 27 studies testing ruxolitinib in Graft vs Host Disease are open now, in 12 countries. Recruiting first, the newest first:
Ohio State University Comprehensive Cancer Center · Sites in United States
Memorial Sloan Kettering Cancer Center · Sites in United States
Bambino Gesù Hospital and Research Institute · Sites in Austria, Czechia, Denmark and 6 more countries
Novartis Pharmaceuticals · Sites in China
Daihong Liu · Sites in China
By country, each count listing its studies:
ruxolitinib: first FDA approval 2011 (JAKAFI), first EMA approval 2012. What it is approved for, and how studies give it, is on its page →
Of the 103 Graft vs Host Disease studies recruiting now, 51 (50%) set no upper age limit and 42 (41%) stop at 75 or younger; 42 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 17 · Phase 3 4 · Phase 4 3
First in 2015; this study’s year is marked. 6 started in 2026.
This study's planned enrollment of 16 is below the median of 35 across 639 interventional studies indexed under Graft vs Host Disease.
Median enrollment 54 across the 27 interventional studies. Of the 11 that completed or were terminated, 7 (64%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 27 have an industry lead sponsor. The 10 most frequent:
Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.
Memorial Sloan Kettering Cancer Center has 9 studies filed under Graft vs Host Disease — fewer than ten, so there is no comparison to draw.
6 of the studies testing ruxolitinib in Graft vs Host Disease that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07238712St. Petersburg State Pavlov Medical UniversityOptimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor | 2026-12-10 |
| NCT06936566John LevineMAGIC Ruxolitinib for aGVHD | 2027-06-01 |
| NCT06008808Washington University School of MedicineRuxolitinib With and Without CTLA-4 Ig Abatacept for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation | 2027-09-08 |
| NCT07796620Peking University People's HospitalSirolimus+Ruxolitinib+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to CNI | 2027-09-30 |
| NCT07356245Ohio State University Comprehensive Cancer CenterRuxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma | 2027-10-31 |
Among the 27 studies testing ruxolitinib in Graft vs Host Disease, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The researchers are doing this study to find out whether the combination of LBP-MARCO (Microbiota Augmentation to Reestablish Commensal Organisms) and ruxolitinib is a safe treatment for people with graft-versus-host disease (GVHD) after receiving a stem cell (allogeneic hematopoietic cell transplantation).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Upper GI aGVHD stage 1 and/or lower GI aGVHD stage 1-4. aGVHD affecting other organs (e.g. skin, liver) are allowed
Exclusion Criteria:
Has received more than one systemic treatment for aGVHD other than +/- CNI or sirolimus prophylaxis or treatment
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in Cohort 1 will receive LBP-MARCO with the same combination of 7 specific types of bacteria.
Drug: Ruxolitinib · Other: LBP- MARCO
If the bacteria do not grow or produce enough metabolites, the next group of participants (Cohort 2) will get LBP-MARCO with a different combination of bacteria.
Drug: Ruxolitinib · Other: LBP- MARCO
If that combination does not grow in participants' guts, the next group of participants (Cohort 3) will get LBP-MARCO with a different combination of the bacteria.
Drug: Ruxolitinib · Other: LBP- MARCO
Ruxolitinib will be initiated concurrently with LBP treatment at a starting dose of 10 mg twice daily and will continue for at least 28 days.
Also known as: Jakafi®
The LBP-MARCO consists of five capsules of individual bacterial strains that will be given at least 1 day apart from one another and within 7-10 days of the first dose.
incidence and severity of SAEs
Grade 2-4 infections by CTCAE v6 either clinically or microbiologically will be assessed throughout the study until day +100. Causality and relationship with aGVHD, LBP-MARCO, and ruxolitinib will be determined.
Time frame: up to 100 days
Microbiota engraftment/PK
is defined as the detection of \> or = to 5 of the 7 consortia commensal strains including butyrate producing taxa detected in stool samples
Time frame: day +7 and/or +14
Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Started Oct 2026 (actual). Primary completion is estimated for Oct 2028, 24 months after the start.
Of 39 non-industry phase 1 interventional studies under Graft vs Host Disease, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 69. This study's planned 24 months is below that.
Counting every sponsor, half of 49 studies reached it within 47 months; a quarter within 24 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Ruxolitinib
Memorial Sloan Kettering Cancer Center →