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Fecal Microbiota Transplantation for the Prevention of Acute Graft Versus Host Disease in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation

Primary Purpose

Acute Graft Versus Host Disease, Hematopoietic and Lymphoid System Neoplasm

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation Capsule
Placebo
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Graft Versus Host Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age >= 18 Signed informed consent Able to take oral medications Planned T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed Planned GVHD prophylaxis using one of the following regimens: Calcineurin inhibitor (tacrolimus or cyclosporine) plus methotrexate Calcineurin inhibitor (tacrolimus or cyclosporine) plus mycophenolate mofetil (MMF) Sirolimus plus cyclosporine plus MMF Post-transplant cyclophosphamide plus calcineurin inhibitor (with or without MMF) One of the following HCT donor types: Human leukocyte antigen (HLA)-matched sibling donor 9/10 or 10/10 HLA-matched unrelated donor HLA- haploidentical donor Cord blood Willing to use at least 1 accepted method of contraception until day 180 after transplant and agree to not donate eggs/sperm for 180 days after Not pregnant or breast feeding ELIGIBILITY CRITERIA FOR RANDOMIZATION: Resolution of all acute toxicities (other than anemia and thrombocytopenia) to Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or lower ELIGIBILITY CRITERIA FOR RANDOMIZATION: Ability to swallow capsules ELIGIBILITY CRITERIA FOR RANDOMIZATION: No grade III-IV acute GVHD ELIGIBILITY CRITERIA FOR RANDOMIZATION: No concurrent antibacterial antibiotics except to those to prevent PCP infection as standard of care. Exclusion Criteria: Severe food allergy in the form of anaphylaxis or attributable symptoms requiring hospitalization History of chronic aspiration Receiving or planned to receive other experimental agents (including ex vivo T-cell depletion) to prevent GVHD

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group I (fecal microbiota transplant)

Group II (Placebo)

Arm Description

Patients receive fecal microbiota capsules PO QD for 7 days

Patients receive placebo PO QD for 7 days

Outcomes

Primary Outcome Measures

Grade III-IV acute graft versus host disease (GVHD)
Based on IBMTR criteria and measured as a probability

Secondary Outcome Measures

Grade II-IV acute GVHD
Based on IBMTR criteria and measured as a probability
Non-relapse mortality
Death not due to relapse/progression of the underlying hematologic disorder and measured as a probability
Clostridium difficile diarrhea
Based on a positive stool assay in the consistent clinical setting (e.g. diarrhea) and measured as a probability

Full Information

First Posted
August 30, 2023
Last Updated
October 12, 2023
Sponsor
Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT06026371
Brief Title
Fecal Microbiota Transplantation for the Prevention of Acute Graft Versus Host Disease in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation
Official Title
Fecal Microbiota Transplantation to Prevent Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized placebo-controlled double-blind phase II trial tests whether fecal microorganism (microbiota) transplantation prevents severe acute graft versus host disease in adults undergoing allogeneic hematopoietic cell transplantation (HCT). Fecal microbiota transplantation involves receiving processed fecal material orally after allogeneic HCT in order to establish a healthy gut microbiota. Gut microbiota undergoes major alterations during allogeneic HCT because of antibiotic exposures, nutritional changes, and chemotherapy administration. Establishing a healthy gut microbiota via fecal transplantation may help prevent acute graft versus host disease in patients undergoing allogeneic HCT.
Detailed Description
OUTLINE: The first 12 patients are assigned to group I, remaining patients are randomized to 1 of 2 groups. GROUP I: Patients receive fecal microbiota capsules orally (PO) once daily (QD) for 7 days starting at the time of neutrophil engraftment and discontinuation of anti-bacterial antibiotics. GROUP II: Patients receive placebo PO QD for 7 days starting at the time of neutrophil engraftment and discontinuation of anti-bacterial antibiotics. After completion of study intervention, patients are followed up monthly until 180 days post-allogeneic HCT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Graft Versus Host Disease, Hematopoietic and Lymphoid System Neoplasm

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
The first 12 patients are assigned to the treatment group, remaining patients are randomized to treatment or placebo group.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Investigators, treating physicians, staff, and subjects are blinded to study arm assignment (FMT vs. placebo).
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (fecal microbiota transplant)
Arm Type
Experimental
Arm Description
Patients receive fecal microbiota capsules PO QD for 7 days
Arm Title
Group II (Placebo)
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo PO QD for 7 days
Intervention Type
Drug
Intervention Name(s)
Fecal Microbiota Transplantation Capsule
Other Intervention Name(s)
Fecal Microbiota Preparation Delivery Capsule, FMPCapDE, FMT Capsule DE, FMT Capsule Delivery, FMT DE Capsule
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Grade III-IV acute graft versus host disease (GVHD)
Description
Based on IBMTR criteria and measured as a probability
Time Frame
Up to 6 months post hematopoietic cell transplantation (HCT)
Secondary Outcome Measure Information:
Title
Grade II-IV acute GVHD
Description
Based on IBMTR criteria and measured as a probability
Time Frame
Up to 6 months post HCT
Title
Non-relapse mortality
Description
Death not due to relapse/progression of the underlying hematologic disorder and measured as a probability
Time Frame
Up to 6 months post HCT
Title
Clostridium difficile diarrhea
Description
Based on a positive stool assay in the consistent clinical setting (e.g. diarrhea) and measured as a probability
Time Frame
Up to 6 months post HCT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 Signed informed consent Able to take oral medications Planned T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed Planned GVHD prophylaxis using one of the following regimens: Calcineurin inhibitor (tacrolimus or cyclosporine) plus methotrexate Calcineurin inhibitor (tacrolimus or cyclosporine) plus mycophenolate mofetil (MMF) Sirolimus plus cyclosporine plus MMF Post-transplant cyclophosphamide plus calcineurin inhibitor (with or without MMF) One of the following HCT donor types: Human leukocyte antigen (HLA)-matched sibling donor 9/10 or 10/10 HLA-matched unrelated donor HLA- haploidentical donor Cord blood Willing to use at least 1 accepted method of contraception until day 180 after transplant and agree to not donate eggs/sperm for 180 days after Not pregnant or breast feeding ELIGIBILITY CRITERIA FOR RANDOMIZATION: Resolution of all acute toxicities (other than anemia and thrombocytopenia) to Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or lower ELIGIBILITY CRITERIA FOR RANDOMIZATION: Ability to swallow capsules ELIGIBILITY CRITERIA FOR RANDOMIZATION: No grade III-IV acute GVHD ELIGIBILITY CRITERIA FOR RANDOMIZATION: No concurrent antibacterial antibiotics except to those to prevent PCP infection as standard of care. Exclusion Criteria: Severe food allergy in the form of anaphylaxis or attributable symptoms requiring hospitalization History of chronic aspiration Receiving or planned to receive other experimental agents (including ex vivo T-cell depletion) to prevent GVHD
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Armin Rashidi
Phone
206-667-2506
Email
arashidi@fredhutch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Rashidi
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armin Rashidi
Phone
206-667-2506
Email
arashidi@fredhutch.org
First Name & Middle Initial & Last Name & Degree
Armin Rashidi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Fecal Microbiota Transplantation for the Prevention of Acute Graft Versus Host Disease in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation

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