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

NCT02805075 | Completed Phase 1 DMC

• 4 other identifiers: BMT303NCI-2016-0084737379P30CA124435
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Recurrent Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Supportive care (Fructooligosaccharide)

EXPERIMENTAL

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; Other: Laboratory Biomarker Analysis

Interventions

Fructooligosaccharide OTHER

Given PO

Supportive care (Fructooligosaccharide)

Laboratory Biomarker Analysis OTHER

Correlative studies

Supportive care (Fructooligosaccharide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnant or nursing patients will not be included in the study

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

fructooligosaccharide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Andrew Rezvani

  Stanford University

  PRINCIPAL INVESTIGATOR

• Tessa Andermann

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 17, 2016
• Study Start: June 1, 2016
• Primary Completion: November 17, 2017
• Study Completion: November 17, 2017
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

US (1)