Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Stanford University
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
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
Clareo Health | Fructooligosaccharides in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant
