Acute GVHD Clinical Trial
Official title:
A Phase I/II Trial of the Prebiotic Galacto-oligosaccharide to Prevent Acute GVHD
Verified date | April 2024 |
Source | Duke University |
Contact | Andrea Pires |
Phone | 9196684978 |
andrea.pires[@]duke.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether the carbohydrate prebiotic (dietary supplement) known as galacto-oligosaccharide (GOS) can modulate the microbiome (the bacteria in the gut) and help prevent graft-versus host disease (GVHD) after allogeneic stem cell transplant. The study has two two parts. In phase 1, the best dose of GOS will be evaluated. In phase 2, using the best dose of GOS, participants will be randomized to receive GOS or a placebo (maltodextrin, a common food additive that is not known to affect the microbiome) so that the effect of GOS can be determined.
Status | Recruiting |
Enrollment | 128 |
Est. completion date | February 1, 2028 |
Est. primary completion date | June 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Plan to undergo allogeneic HCT for any cancer or non-cancer illness - Age 18-80 years - Karnofsky Performance Status >70 Exclusion Criteria: - Pregnant/lactating - Malabsorption syndrome, short bowel or chologenic diarrhea - At time of enrollment, Grade 2 or higher GI symptoms per NCI-CTCAE - Active treatment with other prebiotics, probiotics, or herbal supplementation (ok if stops before enrollment) - Active treatment with antibiotics (with the exception of prophylactic antibiotics) - Concurrent enrollment on the Duke HCT Home Transplant study or another clinical trial targeting GVHD; patients who are enrolled in observational or non-pharmacologic intervention trials (for example, the Duke HCT Research-POP Pre and Peri-HCT Optimization Program aka "R-POP") or pharmacologic or cellular therapy trials with other targets (for example, NK DLI) are NOT excluded |
Country | Name | City | State |
---|---|---|---|
United States | Duke | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | provisional Maximum Tolerated Dose (pMTD) of GOS | GOS will be dosed as outlined using a modified 3+3 design: 0.75g x 4 days, followed by 1.5g x 4 days, followed by 2.9g for the duration of the study. If two or more subjects experience new grade 2 or 3 pre-HCT toxicities at a given dose level, that dose will be considered not tolerable and the previous dose pMTD. If two or more subjects experience new grade 2 or higher pre-HCT toxicities at the 0.75g/day dose, study may be paused to revisit the design. If one subject experiences new grade 2 or 3 pre-HCT toxicities at a given dose level, additional 3 subjects will be enrolled at this same dose schedule. If one or more of these additional subjects experience new grade 2 or 3 pre-HCT toxicities at that same or lower dose level, this dose level will be considered not tolerable and the previous dose the pMTD. If no subjects experience new grade 2 or 3 pre-HCT toxicities or only one of six subjects experience new grade 2 or 3 pre-HCT toxicities, 2.9g/day dose will be assumed to be the pMTD | 30 days | |
Primary | Incidence of Grade II-IV acute GVHD at Day 100 | Acute GVHD Scoring will be done following BMT CTN, 2013 criteria. | 100 days | |
Secondary | Incidence of acute GI toxicities through Day 30 | Acute GI toxicities include mucositis, nausea, vomiting, diarrhea, constipation, abdominal pain, and bloating through D30 as assessed by CTCAE v5. | 30 days | |
Secondary | Incidences of Acute GI toxicities as measured by self-reported evaluation through Day 30 | Acute GI toxicities as measured by self-reported (PRO-CTCAE) evaluation of decreased appetite, anxiety, sadness, fatigue, insomnia, general pain, shortness of breath, numbness and tingling, mouth sores, nausea, vomiting, diarrhea, constipation, abdominal pain, and bloating through D 30 (5 point ordinal scale per PRO-CTCAE) | 30 days | |
Secondary | Incidence of chronic GVHD at Day 365 and Day 730 | Chronic GVHD Scoring will be done following NIH Consensus Criteria | Day 365 and day 730 | |
Secondary | Health care utilization through Day 100, through Day 365, and through Day 730 | Data will be obtained through chart review at or after Day 100, Day 365, and Day730 (respectively), and will be reported as means/medians depending on the distribution of data (for example, mean/median health care utilization through Day 100) | Day 100, Day 365, and Day 730 | |
Secondary | Overall survival (OS) at Day 365 and Day 730 | Data will be obtained by chart review at or after D365 and D730 Data will be reported as a percentage (ie. 1-year and 2-year overall survival) for each arm | Day 365 and Day 730 | |
Secondary | Relapse-free survival (RFS) at Day 365 and Day 730 | Data will be obtained by chart review at or after Day 365 and Day 730 Data will be reported as a percentage (ie. 1-year and 2-year overall survival) for each arm | Day 365 and Day 730 | |
Secondary | Total parenteral nutrition (TPN) use through Day 30 and Day 100 | Data will be obtained as part of the GVHD Prophylaxis/medication assessments. Data will be reported as a percentage for each arm (at each of the time points) | Day 30 and Day 100 |
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