Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD) is a complication of allogeneic stem cell transplant which is usually treated with steroids. You are being asked to take part in this study because you have recently been diagnosed with GI-GVHD. The standard of care for GI-aGVHD is steroids. When aGVHD does not respond to steroids it is described as steroid-refractory aGVHD. There is no standard therapy for steroid-refractory GI-aGVHD. This study is a Phase II study. The main goal of a Phase II study is to see the efficacy and what side effects are seen with FMT as a treatment for GVHD. Fecal Microbiota Transplantation (FMT) is the transfer of fecal material from a healthy donor to a patient in order to restore the diversity of the intestinal microbiota. FMT is currently indicated for the treatment of recurrent Clostridium Difficile infection. FMT is considered experimental in this study, meaning it is not approved by the FDA for the treatment of GVHD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
1 dose = 30 capsules on day 1 of Fecal Microbiota Transplantation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Number of participants experiencing toxicity
Toxicity is defined as: * Any bacterial or fungal infection that can be definitely attributed to FMT. * Any grade 3 or more adverse event that occurs during or immediately after receiving the treatment and is definitely attributed to FMT.
Time frame: up to 6 months from start of treatment
Efficacy of FMT therapy in high risk and in steroid refractory GI-aGVHD as defined as number of responses at day 28 (+/- 3 days) post FMT treatment
Response will be determined from the maximum GI-aGVHD stage and grade at day 28 (+/- 3 days) post FMT treatment. Response will be determined by P.I and a second physician. * Complete response (CR) is defined as the complete resolution of GI aGVHD symptoms, without secondary GVHD therapy. * Partial response (PR) is defined as improvement without complete resolution and without worsening of GI aGVHD, without secondary aGVHD therapy. * No response (NR) is defined as the same grade of GVHD, progression, death, or the addition of secondary GVHD therapy. * Progression is defined as worsening GI aGVHD.
Time frame: 28 days (+/- 3 days) post FMT treatment
Non-relapse mortality (NRM) as measured by percentage of participants who die not related to relapse
Non-relapse mortality (NRM) as measured by percentage of participants who die not related to relapse
Time frame: up to 6 months from start of treatment
Relapse as measured by percentage of participants who relapse
Relapse as measured by percentage of participants who relapse
Time frame: up to 6 months from start of treatment
Relapse-related mortality as measured by percentage of participants with death related to relapse
Relapse-related mortality as measured by percentage of participants with death related to relapse.
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Time frame: up to 6 months from start of treatment
Percentage of participants who develop cGVHD by the end of trial
Percentage of participants who develop cGVHD by the end of trial
Time frame: up to 6 months from start of treatment
Overall survival (OS) as measured by percentage of participants who are alive at end of trial
Overall survival (OS) as measured by percentage of participants who are alive at end of trial
Time frame: up to 6 months from start of treatment
Percentage of patients who discontinue steroids at the end of the study
Percentage of patients who discontinue steroids at the end of the study.
Time frame: up to 6 months from start of treatment