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OncoMatch/Clinical Trials/NCT04177004

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

Is NCT04177004 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for allogeneic hematopoietic stem cell transplant recipient.

Phase 1RecruitingCity of Hope Medical CenterNCT04177004Data as of May 2026

Treatment: Cyclophosphamide · Etoposide · Goat Milk · Palifermin · Sirolimus · TacrolimusThis 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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Multiple Myeloma

Myelodysplastic Syndrome

Chronic Lymphocytic Leukemia

Prior therapy

Cannot have received: investigational agent

Research participants receiving any other investigational agents

Lab requirements

Kidney function

Measured creatinine clearance more than 60 mL/min

Liver function

Total serum bilirubin < 2 times upper limit of normal; ALT/AST <= 2.5 x the upper normal limit; alkaline phosphatase <= 2.5 x the upper normal limit

Cardiac function

Ejection fraction measured by echocardiogram or MUGA > 50%

Ejection fraction measured by echocardiogram or multi gated acquisition scan (MUGA) > 50%; Total serum bilirubin < 2 times upper limit of normal; ALT/AST <= 2.5 x the upper normal limit; alkaline phosphatase <= 2.5 x the upper normal limit; Measured creatinine clearance more than 60 mL/min

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope Medical Center · Duarte, California

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