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

Primary Purpose

Hematopoietic and Lymphoid Cell Neoplasm, Recurrent Hematologic Malignancy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Fructooligosaccharide

Laboratory Biomarker Analysis

About this trial

This is an interventional supportive care trial for Hematopoietic and Lymphoid Cell Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (Fructooligosaccharide)

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum tolerated dose defined as the ability to take 70% of all doses over 21 days

Will employ the Bayesian optimal interval design.

Secondary Outcome Measures

Full Information

NCT ID

NCT02805075

First Posted

June 15, 2016

Last Updated

March 18, 2021

Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02805075

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

June 2016 (undefined)

Primary Completion Date

November 17, 2017 (Actual)

Study Completion Date

November 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematopoietic and Lymphoid Cell Neoplasm, Recurrent Hematologic Malignancy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Supportive care (Fructooligosaccharide)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Fructooligosaccharide

Intervention Description

Given PO

Intervention Type

Other

Intervention Name(s)

Laboratory Biomarker Analysis

Intervention Description

Correlative studies

Primary Outcome Measure Information:

Title

Maximum tolerated dose defined as the ability to take 70% of all doses over 21 days

Description

Will employ the Bayesian optimal interval design.

Time Frame

At day 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Rezvani

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tessa Andermann

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University, School of Medicine

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

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

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