Fecal Microbiota Transplantation (FMT) in Recipients After Allogeneic Hematopoietic Cell Transplantation (HCT)

NCT03720392 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 18-293
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying the role fecal microbiota transplantation may play in post-Hematopoietic Cell Transplantation (HCT) recipients

Conditions

Allogeneic Hematopoietic Cell Transplantation (HCT)

Keywords

Allogeneic Hematopoietic Cell Transplantation (HCT)

Outcome Measures

Primary Outcomes (1)

• The Proportion of Patients Who Achieve Gut Microbiome Diversity at One Month Following the Final Post-HCT FMT

  Gut microbiome diversity will be assessed using urinary 3-indoxyl sulfate (3-IS) levels, with 35 umol/mmol creatinine as the cutoff (≥ 35: diverse; \< 35: not diverse).

  1 Month

Secondary Outcomes (6)

• Number of Participants With Acute Graft-Versus-Host-Disease (GvHD)

  6 months

• Number of Participants With Non-relapse-mortality

  6 Months and 12 months

• Number of Participants With Infection at 100 Days

  100 Days

• Number of Participants With Progression Free Survival at 12 Months Post-treatment

  12 Months

• Overall Survival

  12 Months

Study Arms (2)

FMT Capsules

EXPERIMENTAL

* Two doses of FMT: one standard dose starting within four (4) days from the start of the conditioning regimen prior to HCT and one non-standard dose starting within 4 weeks after engraftment after HCT. * A standard dose of oral FMT is 15 capsules per day for two consecutive days,

Drug: FMT

Placebo Capsules

PLACEBO COMPARATOR

* Two doses of placebo, instead of FMT: one starting within four (4) days from the start of the conditioning regimen prior to HCT and the second one starting within 4 weeks after engraftment after HCT. * A standard dose of oral Placebo is 15 capsules per day for two consecutive days,

Drug: Placebo

Interventions

FMT DRUG

FMT is a process utilizing microbial components which are the good, healthy bacteria that would otherwise naturally occur in the body.

FMT Capsules

Placebo DRUG

a harmless pill, medicine, or procedure prescribed more for the psychological benefit to the patient than for any physiological effect.

Placebo Capsules

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women ≥ 18 and ≤ 80 years old
• Patients designated to undergo myeloablative or intermediate intensity allogeneic peripheral blood or bone marrow hematopoietic cell transplantation. Consent will be obtained prior to admission for HSCT. Patients receiving any donor source of stem cells are eligible. Eligible conditioning regimens are those defined as myeloablative by the ASBMT Consensus Criteria (Bacigalupo 2009) as well as the combination of fludarabine with melphalan (100-140 mg/mg2)
• Any GVHD prophylaxis regimen is allowed.
• ECOG performance status ≤ 2 (Karnofsky ≥ 60%, see Appendix A)
• Patients with adequate physical function as measured by
• Cardiac: Left ventricular ejection fraction at rest must be ≥ 40%, or shortening fraction \>25%
• Hepatic:
• Bilirubin ≤ 2.5 mg/dL, except for patients with Gilbert's syndrome or hemolysis
• ALT, AST, and Alkaline Phosphatase \< 5 x ULN
• Renal: Serum creatinine within normal range, or if serum creatinine is outside normal range, then renal function (measured or estimated creatinine clearance or GFR) ≥ 40mL/min/1.73m2
• Pulmonary: DLCO (corrected for hemoglobin), FEV1 and FVC ≥ 50% predicted
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test, which must be negative, on Study Day 1, prior to receiving FMT. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after FMT.
• Ability to understand and the willingness to sign a written informed consent document, including the willingness to accept risk of unrelated donor stool.
• Ability to swallow large capsules.

You may not qualify if:

• Prior allogeneic hematopoietic stem cell transplantation. (Patients may have received a prior autologous hematopoietic stem cell transplant.)
• Participants who are receiving any other investigational agents.
• Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with active or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
• Planned use of prophylactic donor lymphocyte infusion (DLI) therapy.
• Delayed gastric emptying syndrome or large hiatal hernia
• Known chronic aspiration
• Participants with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs)
• Pregnant and breast-feeding women are ineligible because they are not eligible for hematopoietic stem cell transplantation.
• HIV-positive participants are ineligible.
• Participants who are unable to swallow pills.
• Participants with end-stage liver disease (cirrhosis)
• Participants with acute, active gastrointestinal infection (e.g., typhlitis, diverticulitis, appendicitis)
• Participants with inflammatory bowel disease (e.g., ulcerative colitis, Crohn's)
• Prior total colectomy

Sponsors & Collaborators

• Zachariah Michael DeFilipp: lead

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02214, United States

Location

Results Point of Contact

• Title: Zachariah DeFilipp, MD
• Organization: Massachusetts General Hospital

ZDEFILIPP@MGH.HARVARD.EDU

617-643-3944

Study Officials

• Zachariah DeFilipp, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 25, 2018
• Study Start: January 15, 2019
• Primary Completion: May 28, 2020
• Study Completion: May 28, 2020
• Last Updated: December 1, 2021
• Results First Posted: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)