Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant
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.
Timeline
- Start
- 2021-04-30
- Primary completion
- 2025-12-29
- Completion
- 2026-10-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Human Lysozyme Goat Milk | Protein / enzyme biologic | 250 ml | Oral |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Etoposide | Small molecule | — | Intravenous |
| Background | Palifermin | Protein / enzyme biologic | — | Intravenous |
| Background | Sirolimus | Small molecule | — | Oral |
| Background | Tacrolimus | Small molecule | — | Intravenous |