Fecal Microbiota Transplantation For The Treatment Of Gastro-Intestinal Acute GVHD

NCT ID: NCT04059757

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2023-09-30

Brief Summary

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.

Conditions

Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fecal Microbiota Transplantation (FMT)

One dose of FMT equal to 30 capsules will be administered on day 1 of a 28 day cycle. Steroids and routine GVHD prophylaxis medications and antibiotics may be administered concurrently with FMT therapy.

Participants will be followed for 28 days following completion of the FMT dose or protocol defined outcome.

aGVHD will be treated as per standard of care.

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation (FMT)

Intervention Type: BIOLOGICAL

1 dose = 30 capsules on day 1 of Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation (FMT)

1 dose = 30 capsules on day 1 of Fecal Microbiota Transplantation

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• One of the following diagnosis:
• High risk aGVHD (either biopsy proven or clinical diagnosed) (see Appendix B & C) as defined by either:

• Lower gastrointestinal (GI) stage 3+
• Hyper-acute GVHD as defined by aGVHD of the GI tract within the first 14 days of transplant AND
• Subjects with treatment-naive acute GVHD as defined as those who have not received previous systemic treatment for acute GVHD, except for a maximum of 7 days of no less than 1 mg/kg/day of methyl-prednisolone (or equivalent dose of prednisone).

OR:

• Steroid refractory aGVHD of the GI tract (either biopsy proven or clinical diagnosed) as defined by:

• no response to steroid treatment (minimum daily dose: 2 mg/kg methyl-prednisolone or equivalent) lasting at least 7 days, or
• progression of at least one grade within the first 72 h of treatment
• ECOG Performance status < 3
• Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source.
• Patients who are able stop prophylactic antibiotics during the treatment period
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Active malignancy
• Patients with any concurrent uncontrolled clinically significant medical condition including active infection, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.
• Pregnant or breastfeeding women
• Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
• Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
• Patients with any severe gastrointestinal condition other than GI-GVHD.
• Inability (e.g. dysphagia) to or unwilling to swallow capsules
• Active gastrointestinal infection at time of enrollment
• Known or suspected toxic megacolon and/or known small bowel ileus
• Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy
• History of total colectomy or bariatric surgery
• Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy
• Unable or unwilling to comply with protocol requirements
• Expected life expectancy < 6 months
• Patients who have CMV >2,000 copies/mL of whole blood or EBV >2,000 copies/mL of whole blood.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leland Metheny

OTHER

Sponsor Role: lead

Responsible Party

Leland Metheny

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Leland Metheny, MD

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE4Z19

Identifier Type: -

Identifier Source: org_study_id