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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT02805075
Collaborator
National Cancer Institute (NCI) (NIH)
15
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1
17.5
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fructooligosaccharide
  • Other: Laboratory Biomarker Analysis
Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Single Arm Dose-Escalation Trial of Fructo-Oligosaccharides in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Nov 17, 2017
Actual Study Completion Date :
Nov 17, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supportive care (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.

Other: Fructooligosaccharide
Given PO

Other: Laboratory Biomarker Analysis
Correlative studies

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University, School of Medicine Palo Alto California United States 94304

Sponsors and Collaborators

  • Stanford University
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Andrew Rezvani, Stanford University
  • Principal Investigator: Tessa Andermann, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrew Rezvani, Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier:
NCT02805075
Other Study ID Numbers:
  • BMT303
  • NCI-2016-00847
  • 37379
  • P30CA124435
First Posted:
Jun 17, 2016
Last Update Posted:
Mar 23, 2021
Last Verified:
Mar 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2021