NCT07913672 · Memorial Sloan Kettering Cancer Center
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
What this study is about
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).
View original scientific description
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).
Interventions
DRUG
Ruxolitinib
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.
OTHER
LBP- MARCO
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.
Primary outcome measures
incidence and severity of SAEs
Time frame: up to 100 days
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Ability to swallow capsules
- Have undergone allo-HCT from any donor source
- Upper GI aGVHD stage 1 and/or lower GI aGVHD stage 1-4. aGVHD affecting other organs (e.g. skin, liver) are allowed
- Steroid-refractory, steroid-dependent or intolerant, defined as:
- Progressive (i.e., increase in stage of the lower GI tract) after 3 days of treatment with corticosteroids (≥1 mg/kg/day prednisone or IV equivalent), or
- Failure to improve (i.e., decrease in stage in the GI tract) after 5 days of corticosteroid treatment (≥1 mg/kg/day prednisone or IV equivalent), or
- Incomplete response after \>28 days of corticosteroids, or
- Corticosteroid dependent (inability to taper prednisone \<1 mg/kg/day or recurrence of aGVHD activity or flare during steroid taper), or
- Corticosteroid intolerance (unacceptable toxicity due to the use of corticosteroids).
- Absolute neutrophil count (ANC) ≥0.5 x10\^9/L and platelets \>20,000/mm3. Use of growth factor supplementation and platelet transfusional support is allowed
- Ability to start ruxolitinib therapy for aGVHD
Exclusion criteria
- Has received more than one systemic treatment for aGVHD other than corticosteroids +/- CNI or sirolimus prophylaxis or treatment
- Active GI bleeding requiring intervention or transfusional support
- Toxic megacolon
- Active uncontrolled infection requiring systemic antibiotic treatment including persistent bacteremia (controlled infection receiving definitive therapy for 48 hours prior to enrollment are eligible).
- Treatment with broad spectrum antibiotic with anaerobic coverage for 48 hours prior to enrollment
- Elevated total bilirubin not caused by GVHD or Gilbert's disease of \>5 x upper limit of normal (ULN)
- Use of investigational agent within 14 days pre-treatment
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
- Uncontrolled psychiatric illness
- Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 3 years. Exceptions include adequately treated localized non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance
- Female patient who is pregnant or breastfeeding
- Known allergy or sensitivity to ruxolitinib and/or MARCO live biotherapeutic
Where
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Rockville Centre, New York
Collaborators
University of Chicago
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 3, 2026 · Source of record for eligibility and locations