Graft-versus-host disease after stem cell transplant: testing LBP-MARCO with ruxolitinib

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 1 study evaluates the safety of a combined treatment using LBP-MARCO, a microbiota augmentation product, and ruxolitinib in adults with graft-versus-host disease after allogeneic hematopoietic cell transplantation. Participants have upper GI GVHD stage 1 and/or lower GI GVHD stage 1-4, with various steroid-refractory or -dependent scenarios. The study enrolls adults able to swallow capsules and requires adequate blood counts, with multiple Memorial Sloan Kettering sites and a collaborating center involved. The primary goal is to determine if the combination can be given safely, informing future studies on efficacy and dosing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18
* 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 it's running

• Memorial Sloan Kettering Basking Ridge (Consent Only)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Consent Only)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Consent Only)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk-Commack (Consent Only)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Consent Only)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Doris Ponce, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Doris Ponce, MD
• Email: ponced@mskcc.org
• Phone: 646-608-3739

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.