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Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant
Sponsor: City of Hope Medical Center
Summary
This phase I trial studies the side effects of human lysozyme goat milk in preventing graft versus host disease in patients with blood cancer undergoing a donor stem cell transplant. Sometimes the transplanted cells from a donor can cause an immune response against the body's own normal cells (call graft versus host disease). The goat milk in the study is from goats that have been genetically engineered to produce human lysozyme in the milk. Human lysozyme is a natural enzyme found in human milk and acts as an antimicrobial. Lysozyme is key to the digestive health of breast-fed human infants, since it helps the growth of beneficial gut bacteria and reduces the growth of bacteria that causes diarrhea and intestinal disease. Giving human lysozyme goat milk may reduce the rate of graft versus host disease in blood cancer patients undergoing a donor stem cell transplant.
Official title: A Randomized Pilot Study of Human Lysozyme Goat Milk in Recipients of Standard Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
53
Start Date
2021-04-30
Completion Date
2026-10-27
Last Updated
2025-12-15
Healthy Volunteers
No
Conditions
Interventions
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allo-HCT
Cyclophosphamide
Given IV
Etoposide
Given IV
Fractionated Stereotactic Radiation Therapy
Undergo FTBI
Goat Milk
Given human lysozyme goat milk PO
Palifermin
Given IV
Sirolimus
Given PO
Tacrolimus
Given IV and PO
Locations (1)
City of Hope Medical Center
Duarte, California, United States