Trial Outcomes & Findings for A Study of FMT in Patients With AML Allo HSCT in Recipients (NCT NCT03678493)
NCT ID: NCT03678493
Last Updated: 2024-05-16
Results Overview
Number of infections infections until 4 months after the first intervention. Monitored each visit through safety assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
4 Months
Results posted on
2024-05-16
Participant Flow
Participant milestones
| Measure |
AML Patients Undergoing Intensive Chemotherapy
Fecal Microbiota Transplant (FMT): Oral Capsule
|
AML Patients Undergoing Intensive Chemotherapy Control
Placebo: Oral Capsule
|
Patients Undergoing Allo-HCT
Fecal Microbiota Transplant (FMT): Oral Capsule
|
Patients Undergoing Allo-HCT Control
Placebo: Oral Capsule
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
8
|
49
|
25
|
|
Overall Study
COMPLETED
|
18
|
8
|
49
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of FMT in Patients With AML Allo HSCT in Recipients
Baseline characteristics by cohort
| Measure |
AML Patients Undergoing Intensive Chemothera
n=18 Participants
Fecal Microbiota Transplant (FMT): Oral Capsule
|
AML Patients Undergoing Intensive Chemotherapy Control
n=8 Participants
Placebo: Oral Capsule
|
Patients Undergoing Allo-HCT Patients
n=49 Participants
Fecal Microbiota Transplant (FMT): Oral Capsule
|
Patients Undergoing Allo-HCT Patients Control
n=25 Participants
Placebo: Oral Capsule
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
8 participants
n=7 Participants
|
49 participants
n=5 Participants
|
25 participants
n=4 Participants
|
100 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 MonthsNumber of infections infections until 4 months after the first intervention. Monitored each visit through safety assessment.
Outcome measures
| Measure |
AML Patients Undergoing Intensive Chemotherapy
n=18 Participants
Fecal Microbiota Transplant (FMT): Oral Capsule
|
AML Patients Undergoing Intensive Chemotherapy Control
n=8 Participants
Placebo: Oral Capsule
|
Patients Undergoing Allo-HCT
n=49 Participants
Fecal Microbiota Transplant (FMT): Oral Capsule
|
Patients Undergoing Allo-HCT Control
n=25 Participants
Placebo: Oral Capsule
|
|---|---|---|---|---|
|
Efficacy of FMT in AML Patients and Allo-HCT Recipients - Number of Infections
|
1.12 Infections
Interval 0.57 to 1.67
|
1.50 Infections
Interval 0.35 to 2.65
|
0.89 Infections
Interval 0.6 to 1.19
|
1.09 Infections
Interval 0.55 to 1.64
|
SECONDARY outcome
Timeframe: 2 Weeks after first FMT treatmentPopulation: Only a subset of patients were evaluable for engraftment analysis. This is because they either didn't provide a sample or their sample didn't meet the quality criteria.
Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.
Outcome measures
| Measure |
AML Patients Undergoing Intensive Chemotherapy
n=9 Participants
Fecal Microbiota Transplant (FMT): Oral Capsule
|
AML Patients Undergoing Intensive Chemotherapy Control
n=34 Participants
Placebo: Oral Capsule
|
Patients Undergoing Allo-HCT
Fecal Microbiota Transplant (FMT): Oral Capsule
|
Patients Undergoing Allo-HCT Control
Placebo: Oral Capsule
|
|---|---|---|---|---|
|
FMT Engraftment
|
0.3192 Proportion of Donor Microbiome FMT
Interval 0.0 to 0.301
|
0.1117 Proportion of Donor Microbiome FMT
Interval 0.0 to 0.2675
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 Weeks after first FMT treatmentPopulation: Only a subset of patients were evaluable for engraftment analysis. This is because they either didn't provide a sample or their sample didn't meet the quality criteria.
Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.
Outcome measures
| Measure |
AML Patients Undergoing Intensive Chemotherapy
n=1 Participants
Fecal Microbiota Transplant (FMT): Oral Capsule
|
AML Patients Undergoing Intensive Chemotherapy Control
n=18 Participants
Placebo: Oral Capsule
|
Patients Undergoing Allo-HCT
Fecal Microbiota Transplant (FMT): Oral Capsule
|
Patients Undergoing Allo-HCT Control
Placebo: Oral Capsule
|
|---|---|---|---|---|
|
FMT Engraftment
|
0.4767 Proportion of Donor Microbiome FMT
|
0.2626 Proportion of Donor Microbiome FMT
Interval 0.0 to 0.2452
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 180 post-HCT, up to 7 monthsPercentage of Participants with Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV). Monitored each visit through safety assessment. Grade II better, Grade IV worse.
Outcome measures
| Measure |
AML Patients Undergoing Intensive Chemotherapy
n=49 Participants
Fecal Microbiota Transplant (FMT): Oral Capsule
|
AML Patients Undergoing Intensive Chemotherapy Control
n=25 Participants
Placebo: Oral Capsule
|
Patients Undergoing Allo-HCT
Fecal Microbiota Transplant (FMT): Oral Capsule
|
Patients Undergoing Allo-HCT Control
Placebo: Oral Capsule
|
|---|---|---|---|---|
|
Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)
|
29.8 Percentage of participants
Interval 16.5 to 43.0
|
8 Percentage of participants
Interval 0.0 to 19.6
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 week after first FMT treatmentNumber of BSI of suspected gut origin. Monitored each visit through safety assessment.
Outcome measures
| Measure |
AML Patients Undergoing Intensive Chemotherapy
n=18 Participants
Fecal Microbiota Transplant (FMT): Oral Capsule
|
AML Patients Undergoing Intensive Chemotherapy Control
n=8 Participants
Placebo: Oral Capsule
|
Patients Undergoing Allo-HCT
n=49 Participants
Fecal Microbiota Transplant (FMT): Oral Capsule
|
Patients Undergoing Allo-HCT Control
n=25 Participants
Placebo: Oral Capsule
|
|---|---|---|---|---|
|
Number of BSI of Suspected Gut Origin
|
0 Bloodstream infections
|
0 Bloodstream infections
|
1 Bloodstream infections
|
0 Bloodstream infections
|
SECONDARY outcome
Timeframe: 4 Months after first FMT treatmentNumber of Bacterial Infections. Monitored each visit through safety assessment.
Outcome measures
| Measure |
AML Patients Undergoing Intensive Chemotherapy
n=18 Participants
Fecal Microbiota Transplant (FMT): Oral Capsule
|
AML Patients Undergoing Intensive Chemotherapy Control
n=8 Participants
Placebo: Oral Capsule
|
Patients Undergoing Allo-HCT
n=49 Participants
Fecal Microbiota Transplant (FMT): Oral Capsule
|
Patients Undergoing Allo-HCT Control
n=25 Participants
Placebo: Oral Capsule
|
|---|---|---|---|---|
|
Number of Bacterial Infections
|
8 Infections
|
2 Infections
|
10 Infections
|
2 Infections
|
SECONDARY outcome
Timeframe: 4 Months after first FMT treatmentNumber of Viral Infections. Monitored each visit through safety assessment.
Outcome measures
| Measure |
AML Patients Undergoing Intensive Chemotherapy
n=18 Participants
Fecal Microbiota Transplant (FMT): Oral Capsule
|
AML Patients Undergoing Intensive Chemotherapy Control
n=8 Participants
Placebo: Oral Capsule
|
Patients Undergoing Allo-HCT
n=49 Participants
Fecal Microbiota Transplant (FMT): Oral Capsule
|
Patients Undergoing Allo-HCT Control
n=25 Participants
Placebo: Oral Capsule
|
|---|---|---|---|---|
|
Number of Viral Infections
|
2 Infections
|
2 Infections
|
13 Infections
|
8 Infections
|
SECONDARY outcome
Timeframe: 4 Months after first FMT treatmentNumber of Fungal Infections. Monitored each visit through safety assessment.
Outcome measures
| Measure |
AML Patients Undergoing Intensive Chemotherapy
n=18 Participants
Fecal Microbiota Transplant (FMT): Oral Capsule
|
AML Patients Undergoing Intensive Chemotherapy Control
n=8 Participants
Placebo: Oral Capsule
|
Patients Undergoing Allo-HCT
n=49 Participants
Fecal Microbiota Transplant (FMT): Oral Capsule
|
Patients Undergoing Allo-HCT Control
n=25 Participants
Placebo: Oral Capsule
|
|---|---|---|---|---|
|
Number of Fungal Infections
|
0 Infections
|
0 Infections
|
1 Infections
|
0 Infections
|
Adverse Events
AML Patients Undergoing Intensive Chemotherapy
Serious events: 16 serious events
Other events: 16 other events
Deaths: 0 deaths
AML Patients Undergoing Intensive Chemotherapy Control
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Patients Undergoing Allo-HCT
Serious events: 22 serious events
Other events: 22 other events
Deaths: 6 deaths
Patients Undergoing Allo-HCT Control
Serious events: 4 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
AML Patients Undergoing Intensive Chemotherapy
n=18 participants at risk
Fecal Microbiota Transplant (FMT): Oral Capsule
|
AML Patients Undergoing Intensive Chemotherapy Control
n=8 participants at risk
Placebo: Oral Capsule
|
Patients Undergoing Allo-HCT
n=49 participants at risk
Fecal Microbiota Transplant (FMT): Oral Capsule
|
Patients Undergoing Allo-HCT Control
n=25 participants at risk
Placebo: Oral Capsule
|
|---|---|---|---|---|
|
Infections and infestations
Bloodstream infection
|
55.6%
10/18 • Number of events 10 • 9 months
|
25.0%
2/8 • Number of events 2 • 9 months
|
16.3%
8/49 • Number of events 8 • 9 months
|
12.0%
3/25 • Number of events 3 • 9 months
|
|
Immune system disorders
Acute GVHD
|
11.1%
2/18 • Number of events 2 • 9 months
|
0.00%
0/8 • 9 months
|
18.4%
9/49 • Number of events 9 • 9 months
|
0.00%
0/25 • 9 months
|
|
Immune system disorders
Pneumonia
|
0.00%
0/18 • 9 months
|
0.00%
0/8 • 9 months
|
10.2%
5/49 • Number of events 5 • 9 months
|
4.0%
1/25 • Number of events 1 • 9 months
|
|
Immune system disorders
Fever
|
11.1%
2/18 • Number of events 2 • 9 months
|
12.5%
1/8 • Number of events 1 • 9 months
|
0.00%
0/49 • 9 months
|
0.00%
0/25 • 9 months
|
|
Infections and infestations
Urinary tract infection
|
11.1%
2/18 • Number of events 2 • 9 months
|
12.5%
1/8 • Number of events 1 • 9 months
|
0.00%
0/49 • 9 months
|
0.00%
0/25 • 9 months
|
Other adverse events
| Measure |
AML Patients Undergoing Intensive Chemotherapy
n=18 participants at risk
Fecal Microbiota Transplant (FMT): Oral Capsule
|
AML Patients Undergoing Intensive Chemotherapy Control
n=8 participants at risk
Placebo: Oral Capsule
|
Patients Undergoing Allo-HCT
n=49 participants at risk
Fecal Microbiota Transplant (FMT): Oral Capsule
|
Patients Undergoing Allo-HCT Control
n=25 participants at risk
Placebo: Oral Capsule
|
|---|---|---|---|---|
|
Infections and infestations
Bloodstream infection
|
55.6%
10/18 • Number of events 10 • 9 months
|
25.0%
2/8 • Number of events 2 • 9 months
|
16.3%
8/49 • Number of events 8 • 9 months
|
12.0%
3/25 • Number of events 3 • 9 months
|
|
Immune system disorders
Acute GVHD
|
11.1%
2/18 • Number of events 2 • 9 months
|
0.00%
0/8 • 9 months
|
18.4%
9/49 • Number of events 9 • 9 months
|
0.00%
0/25 • 9 months
|
|
Immune system disorders
Pneumonia
|
0.00%
0/18 • 9 months
|
0.00%
0/8 • 9 months
|
10.2%
5/49 • Number of events 5 • 9 months
|
4.0%
1/25 • Number of events 1 • 9 months
|
|
Immune system disorders
Fever
|
11.1%
2/18 • Number of events 2 • 9 months
|
12.5%
1/8 • Number of events 1 • 9 months
|
0.00%
0/49 • 9 months
|
0.00%
0/25 • 9 months
|
|
Infections and infestations
Urinary tract infection
|
11.1%
2/18 • Number of events 2 • 9 months
|
12.5%
1/8 • Number of events 1 • 9 months
|
0.00%
0/49 • 9 months
|
0.00%
0/25 • 9 months
|
Additional Information
Armin Rashidi, MD, PhD
University of Minnesota, Masonic Cancer Center
Phone: (612) 273-8383
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place