CLINICAL TRIAL

Galacto-oligosaccharide for Acute GVHD

Recruiting · 18+ · All Sexes · Durham, NC

This study is evaluating whether a carbohydrate supplement may help prevent graft-versus-host disease after stem cell transplant.

See full description

About the trial for Acute GVHD

Treatment Groups

This trial involves 2 different treatments. Galacto-oligosaccharide is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Galacto-oligosaccharide
DIETARYSUPPLEMENT
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Maltodextrin
DIETARYSUPPLEMENT

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Plan to undergo allogeneic HCT for any cancer or non-cancer illness
Age 18-80 years
Karnofsky Performance Status >70
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 100, Day 365, and Day 730
Screening: ~3 weeks
Treatment: Varies
Reporting: Day 100, Day 365, and Day 730
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 100, Day 365, and Day 730.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Galacto-oligosaccharide will improve 2 primary outcomes and 7 secondary outcomes in patients with Acute GVHD. Measurement will happen over the course of 30 days.

Incidence of acute GI toxicities through Day 30
30 DAYS
Acute GI toxicities include mucositis, nausea, vomiting, diarrhea, constipation, abdominal pain, and bloating through D30 as assessed by CTCAE v5.
30 DAYS
Incidences of Acute GI toxicities as measured by self-reported evaluation through Day 30
30 DAYS
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
provisional Maximum Tolerated Dose (pMTD) of GOS
30 DAYS
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
Incidence of Grade II-IV acute GVHD at Day 100
100 DAYS
Acute GVHD Scoring will be done following BMT CTN, 2013 criteria.
100 DAYS
Total parenteral nutrition (TPN) use through Day 30 and Day 100
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
Relapse-free survival (RFS) at Day 365 and Day 730
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
See More

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is acute gvhd?

Immune disorders are a well-recognized class of diseases in pediatric oncology. They present a significant challenge to pediatric oncologists and pediatricians due to the scarcity of published pediatric data on immune disorders in pediatric oncology. A review of the most commonly published cases on a single subject was done for the purpose of providing an overview on relevant clinical information.\n\nIn 2006, a 10-year-old girl presented with acute gvHD associated with allogeneic haematopoietic stem cell transplant (HSCT). Her symptoms included fever, increased liver enzymes, and skin eruptions, but a bone marrow analysis revealed no signs of overt transplant rejection.

Anonymous Patient Answer

How many people get acute gvhd a year in the United States?

The cumulative average rate of acute GVHD development is 4.5 cases per 10,000 stem cell transplant recipients per year. The incidence of acute GVHD development in patients with a high-risk (i.e., >10% relapse risk) disease pattern is significantly higher than that reported in studies of allo SCT patients.

Anonymous Patient Answer

What causes acute gvhd?

Current gfh can act as a risk factor for developing autoimmune disease later in life, as well as the occurrence of the autoimmune disorder nephritis. Data from a recent study suggest that current gfh may have a causal role in disease.

Anonymous Patient Answer

What are the signs of acute gvhd?

Symptoms of acute gvHD include fever, skin redness, headache, vomiting or gastrointestinal bleeding. There is a high frequency of gvHD in patients with herpesviruses, the most common cause of acute febrile viral encephalitis.

Anonymous Patient Answer

What are common treatments for acute gvhd?

The treatment of acute graft-vs.-host disease (aGVHD) mostly consists of topical treatments, such as corticosteroids or vitamin A analogues such as isotretinoin. If these agents are ineffective, more systemic treatments exist (such as cytoreductive chemotherapy and bone marrow transplantation). Treatment of severe aGVHD depends on the severity of disease and the comorbidities, such as graft reaction, infections, and GVHD.

Anonymous Patient Answer

Can acute gvhd be cured?

Acute gvHD has two main types and is characterized by different levels of Tregs and Th1 cells. Therefore, Tregs and Th1 cells are thought to be the targets of both oral or IVIg therapy.

Anonymous Patient Answer

Does galacto-oligosaccharide improve quality of life for those with acute gvhd?

Administration of GOS may be an effective method for treating patients with acute gvHD. Findings from a recent study suggest that GOS may help improve HRQoL in patients with gvHD.

Anonymous Patient Answer

How does galacto-oligosaccharide work?

We conclude that GOS is effective in reducing the number of episodes of acute-onset gastritis and in reducing the number of bowel movements and abdominal pain after a GI challenge with water-soluble oligosaccharides in children without clinical or biologic signs of intestinal bacterial overgrowth.

Anonymous Patient Answer

Has galacto-oligosaccharide proven to be more effective than a placebo?

Data from a recent study is the first randomized trial to show the superiority of GOS when given in a daily dose of 40 mg/kg orally to non-pregnant, non-delivery-sick infants with acute gastroenteritis compared with placebo. Its administration may decrease duration of acute gastroenteritis and its risk of complications. The safety of GOS was also validated in this study. Clinicaltrials.gov registration number: NCT01393545.

Anonymous Patient Answer

Does acute gvhd run in families?

A common phenotype of GHD in children with and without siblings who develop childhood GHD exists. These data emphasize a common genetic background for pediatric GHD. GHD is unlikely to be caused by chance inheritance from a single, sporadic gene.

Anonymous Patient Answer

What is the average age someone gets acute gvhd?

The average age that children experience a first episode of acute gvHD is 2.8 years, which is later than the age of children diagnosed with chronic gvHD, whose average is 5.6 years.

Anonymous Patient Answer

What is the latest research for acute gvhd?

In summary, current literature supports, and provides evidence for, an association between the pathogen load and severity of acute GVHD. However, more evidence is needed for the correlation between microbial composition and GVHD severity.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Acute GVHD by sharing your contact details with the study coordinator.