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

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ClinicalTrials.gov Identifier: NCT02805075
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Andrew Rezvani, Stanford University

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
Hematopoietic and Lymphoid Cell Neoplasm Recurrent Hematologic Malignancy Other: Fructooligosaccharide Other: Laboratory Biomarker Analysis Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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 : June 2016
Actual Primary Completion Date : November 17, 2017
Actual Study Completion Date : November 17, 2017

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




Primary Outcome Measures :
  1. Maximum tolerated dose defined as the ability to take 80% of all doses over 21 days [ Time Frame: At day 21 ]
    Will employ the Bayesian optimal interval design.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805075


Locations
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United States, California
Stanford University, School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Andrew Rezvani Stanford University
Principal Investigator: Tessa Andermann Stanford University

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Responsible Party: Andrew Rezvani, Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02805075     History of Changes
Other Study ID Numbers: BMT303
NCI-2016-00847 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
37379 ( Other Identifier: Stanford IRB )
P30CA124435 ( U.S. NIH Grant/Contract )
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases