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

Single Arm Dose-Escalation Trial of Fructo-Oligosaccharides in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

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.

Study Overview

• Status: Completed
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Recurrent Hematologic Malignancy
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Fructooligosaccharide

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: Laboratory Biomarker Analysis; Correlative studies; Other: Fructooligosaccharide; Given PO

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Tessa Andermann, Stanford University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): November 17, 2017
• Study Completion (Actual): November 17, 2017

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 17, 2016

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: BMT303; P30CA124435 (U.S. NIH Grant/Contract); NCI-2016-00847 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 37379 (Other Grant/Funding Number: Health Institutes of Turkey)