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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00847 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 37379 | Other Identifier | Stanford IRB | |
| P30CA124435 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fructooligosaccharide | Other | Given PO |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Rezvani | Stanford University | Principal Investigator |
| Tessa Andermann | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C116580 | fructooligosaccharide |
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| Laboratory Biomarker Analysis |
| Other |
Correlative studies |
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