Clinical trial NCT02805075: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Recurrent Hematologic Malignancy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-06-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Maximum tolerated dose defined as the ability to take 70% of all doses over 21 days
timeFrame: At day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Andrew Rezvani
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Tessa Andermann
role: PRINCIPAL_INVESTIGATOR
References: