RecruitingPhase 1NCT04177004

Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant

A Randomized Pilot Study of Human Lysozyme Goat Milk in Recipients of Standard Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation


Sponsor

City of Hope Medical Center

Enrollment

53 participants

Start Date

Apr 30, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether drinking milk from goats that produce human lysozyme — an antibacterial protein found in human breast milk — can help prevent graft versus host disease (GVHD) in patients undergoing allogeneic stem cell transplantation (receiving a stem cell transplant from a donor). GVHD occurs when the donor's immune cells attack the recipient's body and is a major cause of complications and death after transplant. Human lysozyme has natural antimicrobial properties and may help protect the gut lining, which is often damaged by GVHD. Participants will consume the special milk as a supplement alongside their standard post-transplant care. You may be eligible if: - You are 12 years of age or older - You are undergoing an allogeneic stem cell transplant for a blood cancer from a matched related or unrelated donor (8/8 HLA match) - You are receiving a myeloablative conditioning regimen with total body irradiation - Your heart function (ejection fraction > 50%), lung function (DLCO or FVC > 50%), liver tests, and kidney function meet study criteria - You are willing to use birth control during the study and for 90 days after You may NOT be eligible if: - You are lactose intolerant or have a milk product intolerance - You are pregnant or breastfeeding - You have an active or uncontrolled infection (including active hepatitis B or C, or HIV) - You have had another malignancy within the past 2 years (except non-melanoma skin cancer or cervical carcinoma in situ) - You are enrolled in another investigational drug study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAllogeneic Hematopoietic Stem Cell Transplantation

Undergo allo-HCT

DRUGCyclophosphamide

Given IV

DRUGEtoposide

Given IV

RADIATIONFractionated Stereotactic Radiation Therapy

Undergo FTBI

DRUGGoat Milk

Given human lysozyme goat milk PO

BIOLOGICALPalifermin

Given IV

DRUGSirolimus

Given PO

DRUGTacrolimus

Given IV and PO


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT04177004


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