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

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805075
• Other study ID #: BMT303
• Secondary ID: NCI-2016-0084737
• Status: Completed
• Phase: Phase 1
• Start date: June 2016
• Est. completion date: November 17, 2017

Study information

• Verified date: March 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 17, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm
• Recurrent Hematologic Malignancy

Intervention

Other:
• Fructooligosaccharide
Given PO
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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