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
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic and Lymphoid Cell Neoplasm Recurrent Hematologic Malignancy||Other: Fructooligosaccharide Other: Laboratory Biomarker Analysis||Phase 1|
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.
|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|
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: Laboratory Biomarker Analysis
- 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.
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
|United States, California|
|Stanford University, School of Medicine|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Andrew Rezvani||Stanford University|
|Principal Investigator:||Tessa Andermann||Stanford University|