Fructooligosaccharides in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant

Phase 1

Completed

• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Recurrent Hematologic Malignancy
• Interventions: Other: Fructooligosaccharide; Other: Laboratory Biomarker Analysis

• Registration Number: NCT02805075
• Lead Sponsor: Stanford University

Brief Summary

This pilot phase I trial studies the side effects and best dose of fructooligosaccharides in treating patients with blood cancer who are undergoing donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Nutritional supplements such as fructooligosaccharides may reduce the incidence of graft-versus-host disease in patients with blood cancer undergoing donor stem cell transplant.

Detailed Description

PRIMARY OBJECTIVES:

I. Conduct a dose escalation trial to determine the tolerability of the fructo-oligosaccharides prebiotic in allogeneic hematopoeitic stem cell transplant (HSCT) patients.

OUTLINE: This is a dose escalation study.

Patients receive fructooligosaccharides (FOS) orally (PO) twice daily (BID) for 21 days starting at 7 days before allogeneic hematopoietic stem cell transplant in the absence of disease progression or unexpected toxicity.

After completion of study treatment, patients are followed for 100 days.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-17
• Primary Completion: 2017-11-17
• Study Completion: 2017-11-17
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients included in the study will have a hematologic malignancy (any stage or grade) for which they are undergoing preparation for allogeneic HSCT; participants in the study will be restricted to those undergoing HSCT under reduced-intensity protocols 9924 and 9907
• No limitations exist for type or amount of prior therapy
• No restrictions or requirements will be placed on race
• No restrictions will be made based on life expectancy
• Patients will not be evaluated based on Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status (KPS)
• No restrictions will be made based on organ or marrow function
• Patients will be included only if they have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Patients with a history of gastric bypass surgery or inflammatory bowel disease
• Patients with a history of or current bowel obstruction
• Patients actively enrolled on any other GVHD prevention trial
• Patients with known fructose intolerance
• Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures
• Subjects may co-enroll on other investigational studies except for investigational studies whose primary aim is the prevention of GVHD
• No additional restrictions exist regarding co-morbid disease or incurrent illness
• Patients will be excluded from the trial if they have had a history of allergies or intolerance to fructooligosaccharides or the components of FOS including fructose and glucose
• No exclusion is necessary based on the use of other concomitant medications; specifically there is no prohibition of concomitant antibiotic, antiviral or antifungal therapy; subjects may co-enroll on other investigational studies except for investigational studies whose primary aim is the prevention of GVHD
• Pregnant or nursing patients will not be included in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (Fructooligosaccharide)	Fructooligosaccharide	Patients receive FOS PO BID for 21 days starting at 7 days before allogeneic hematopoietic stem cell transplant in the absence of disease progression or unexpected toxicity.
Supportive care (Fructooligosaccharide)	Laboratory Biomarker Analysis	Patients receive FOS PO BID for 21 days starting at 7 days before allogeneic hematopoietic stem cell transplant in the absence of disease progression or unexpected toxicity.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose defined as the ability to take 70% of all doses over 21 days	At day 21	Will employ the Bayesian optimal interval design.

Trial Locations

Locations (1)

Stanford University, School of Medicine; 🇺🇸 Palo Alto, California, United States