Trial Outcomes & Findings for Lactobacillus Rhamnosus GG in Reducing Incidence of Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant (NCT NCT02144701)

NCT ID: NCT02144701

Last Updated: 2021-04-27

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

Baseline

Results posted on

2021-04-27

Participant Flow

Subjects were recruited through the Rutgers Cancer Institute of New Jersey. The study was open to accrual on 02/18/2013 and was closed to accrual on 04/22/2016.

We are reporting results on 33 eligible patients. 18 patients were deemed ineligible.

Participant milestones

Participant milestones
Measure	Lactobacillus Rhamnosus GG Patients receive Lactobacillus rhamnosus GG PO QD for 1 year. Lactobacillus rhamnosus GG: Given PO laboratory biomarker analysis: Correlative studies	no Intervention Patients receive no intervention.
Overall Study STARTED	22	11
Overall Study COMPLETED	13	8
Overall Study NOT COMPLETED	9	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Lactobacillus Rhamnosus GG Patients receive Lactobacillus rhamnosus GG PO QD for 1 year. Lactobacillus rhamnosus GG: Given PO laboratory biomarker analysis: Correlative studies	no Intervention Patients receive no intervention.
Overall Study development of relapse, GVHD or death	9	3

Baseline Characteristics

Lactobacillus Rhamnosus GG in Reducing Incidence of Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Lactobacillus Rhamnosus GG) n=21 Participants Patients receive Lactobacillus rhamnosus GG PO QD for 1 year. Lactobacillus rhamnosus GG: Given PO laboratory biomarker analysis: Correlative studies	Arm II (no Intervention) n=10 Participants Patients receive no intervention.	Total n=31 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
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	7 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	8 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	10 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Arm I (Lactobacillus Rhamnosus GG) n=20 Participants Patients receive Lactobacillus rhamnosus GG PO QD for 1 year. Lactobacillus rhamnosus GG: Given PO laboratory biomarker analysis: Correlative studies	Arm II (no Intervention) n=11 Participants Patients receive no intervention.
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring	10 Participants	4 Participants

PRIMARY outcome

Timeframe: 1 month

Outcome measures

Outcome measures
Measure	Arm I (Lactobacillus Rhamnosus GG) n=10 Participants Patients receive Lactobacillus rhamnosus GG PO QD for 1 year. Lactobacillus rhamnosus GG: Given PO laboratory biomarker analysis: Correlative studies	Arm II (no Intervention) n=4 Participants Patients receive no intervention.
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring	10 Participants	4 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Arm I (Lactobacillus Rhamnosus GG) n=10 Participants Patients receive Lactobacillus rhamnosus GG PO QD for 1 year. Lactobacillus rhamnosus GG: Given PO laboratory biomarker analysis: Correlative studies	Arm II (no Intervention) n=4 Participants Patients receive no intervention.
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring	10 Participants	4 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Arm I (Lactobacillus Rhamnosus GG) n=10 Participants Patients receive Lactobacillus rhamnosus GG PO QD for 1 year. Lactobacillus rhamnosus GG: Given PO laboratory biomarker analysis: Correlative studies	Arm II (no Intervention) n=4 Participants Patients receive no intervention.
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring	10 Participants	4 Participants

PRIMARY outcome

Timeframe: 9 months

Outcome measures

Outcome measures
Measure	Arm I (Lactobacillus Rhamnosus GG) n=10 Participants Patients receive Lactobacillus rhamnosus GG PO QD for 1 year. Lactobacillus rhamnosus GG: Given PO laboratory biomarker analysis: Correlative studies	Arm II (no Intervention) n=4 Participants Patients receive no intervention.
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring	10 Participants	4 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Arm I (Lactobacillus Rhamnosus GG) n=10 Participants Patients receive Lactobacillus rhamnosus GG PO QD for 1 year. Lactobacillus rhamnosus GG: Given PO laboratory biomarker analysis: Correlative studies	Arm II (no Intervention) n=4 Participants Patients receive no intervention.
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring	10 Participants	4 Participants

Adverse Events

Arm I (Lactobacillus Rhamnosus GG)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Arm II (no Intervention)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roger Strair, MD, PhD

Rutgers Cancer Institute of New Jersey

Phone: 732-235-7298

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place