Prebiotic Galacto-Oligosaccharides for the Prevention of Graft Versus Host Disease in Patients Undergoing Donor Hematopoietic Stem Cell Transplant

PRIMARY OBJECTIVE:

I. To evaluate the safety and efficacy of the prebiotic galacto-oligosaccharides (GOS), in mitigating acute graft versus host disease (GVHD) after allogeneic hematopoietic stem cell transplant (HCT).

SECONDARY OBJECTIVES:

I. To evaluate the efficacy of GOS in mitigating acute (through Day 30) gastrointestinal (GI) toxicity.

II. To evaluate the efficacy of GOS in mitigating total parenteral nutrition (TPN) use.

III. To evaluate the efficacy of GOS in mitigating chronic GVHD.

IV. To evaluate the effect of GOS on health care resource utilization (for example, intensive care unit [ICU] admissions and length of stay).

V. To evaluate the effect of GOS on relapse-free survival (RFS).

VI. To evaluate the effect of GOS on overall survival (OS).

EXPLORATORY OBJECTIVES:

I. To evaluate the effect of GOS on gut microbiome density and diversity.

II. To evaluate the effect of GOS on short chain fatty acid (SCFA) levels.

III. To evaluate the effect of GOS on intestinal inflammation and antimicrobial peptides.

IV. To evaluate the effect of GOS on systemic inflammation.

V. To evaluate the effect of GOS on immune profiles and function.

VI. To evaluate the effect of GOS on other metabolic biomarkers.

VII. To evaluate the effect of GOS on the following functional/microbial domains: physical activity, cognitive function, mental health, nutrition and diet, skin microbiota, social support, symptoms, comorbidities, global function, financial toxicity, and polypharmacy.

OUTLINE: This is a phase I dose escalation study of GOS followed by a phase II study.

PHASE I: Patients receive GOS orally (PO) once daily (QD) beginning 30 days before standard of care allogeneic HCT and continuing until 28 days after HCT.

PHASE II: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive GOS PO QD beginning 30 days before standard of care allogeneic HCT and continuing until 28 days after HCT.

ARM II: Patients receive maltodextrin PO QD beginning 30 days before standard of care allogeneic HCT and continuing until 28 days after HCT.

After completion of study treatment, patients are followed up at days 35, 42, 60, 90, 180, 365, and 730.