Status:
TERMINATED
Fecal Microbiota Transplantation With Ruxolitinib and Steroids as an Upfront Treatment of Severe Acute Intestinal GVHD
Lead Sponsor:
St. Petersburg State Pavlov Medical University
Conditions:
Intestinal GVHD
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
Therapy of severe intestinal graft-versus-host disease (GVHD) despite the introduction of novel target agents is associated with worse outcome compared to the other forms. Response to steroids is obse...
Detailed Description
Acute intestinal GVHD grade III-IV after allogeneic stem cell transplantation the form with low effectiveness of corticosteroids. Despite high response rate to systemic immunosupressive agents, long t...
Eligibility Criteria
Inclusion
- Age 5-70 years
- Histologically confirmed gastrointestinal acute GVHD
- Grade III-IV gastrointestinal GVHD based on 2016 MAGIC criteria
- Ability for oral drug intake
- Signed informed consent
Exclusion
- Requirement for oxigen and/or vasopressor support
- Respiratory distress \>grade I
- Severe organ dysfunction: AST or ALT \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits,creatinine clearance \< 60 mL/min
- Ongoing fluconazole therapy
- Any malignancy requiring systemic therapy at the time of enrollment
- Mixed chimerism at last evaluation
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Requirement for vasopressor support at the time of enrollment
- Karnofsky index \<30%
- Severe concurrent illness that can interfere with study procedures
- Somatic or psychiatric disorder making the patient unable to sign informed consent
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2024
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04269850
Start Date
September 1 2019
End Date
November 27 2024
Last Update
December 3 2024
Active Locations (1)
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1
Pavlov First Saint-Petersburg State Medical University
Saint Petersburg, Russia, 197022