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RECRUITING
NCT04177004
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allo-HCT

DRUG

Cyclophosphamide

Given IV

DRUG

Etoposide

Given IV

RADIATION

Fractionated Stereotactic Radiation Therapy

Undergo FTBI

DRUG

Goat Milk

Given human lysozyme goat milk PO

BIOLOGICAL

Palifermin

Given IV

DRUG

Sirolimus

Given PO

DRUG

Tacrolimus

Given IV and PO

Locations (1)

City of Hope Medical Center

Duarte, California, United States