16 Participants NeededMy employer runs this trial

LBP-MARCO + Ruxolitinib for Graft-versus-Host Disease

Recruiting at 6 trial locations
DP
JP
Overseen ByJonathan Peled, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

DP

Doris Ponce, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for people who have developed graft-versus-host disease (GVHD) after receiving a stem cell transplant from another person. Participants must meet certain health requirements and cannot join if they have conditions that would make participation unsafe.

Inclusion Criteria

Ability to swallow capsules
I have stage 1 upper or stage 1-4 lower GI acute GVHD; other organs may also be affected.
I am 18 years old or older.
See 4 more

Exclusion Criteria

Uncontrolled psychiatric illness
Elevated total bilirubin not caused by GVHD or Gilbert's disease >5 x upper limit of normal (ULN)
I am currently pregnant or breastfeeding.
See 9 more

What Are the Treatments Tested in This Trial?

Interventions

  • LBP-MARCO
  • Ruxolitinib

Trial Overview

The study is testing whether combining LBP-MARCO, which aims to restore healthy gut bacteria, with the drug ruxolitinib is safe for treating GVHD. All participants will receive both treatments.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Consortia CExperimental Treatment2 Interventions
Group II: Consortia BExperimental Treatment2 Interventions
Group III: Consortia AExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

University of Chicago

Collaborator

Trials
1,086
Recruited
844,000+