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NCT04177004 · ClinicalTrials.gov registry record · Phase 1
Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant
A Phase 1 study of Hematopoietic and Lymphoid Cell Neoplasm and Allogeneic Hematopoietic Stem Cell Transplant Recipient, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
- 1
- Study location
NCT04177004 is a Phase 1 study of Hematopoietic and Lymphoid Cell Neoplasm and Allogeneic Hematopoietic Stem Cell Transplant Recipient that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 53 participants, below the 952-participant average among 104 other Hematopoietic and Lymphoid Cell Neoplasm trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04177004, a Phase 1 study of Hematopoietic and Lymphoid Cell Neoplasm and Allogeneic Hematopoietic Stem Cell Transplant Recipient, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Etoposide
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- RADIATION Fractionated Stereotactic Radiation Therapy
- DRUG Goat Milk
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2021-04-30 |
| Est. Completion | 2026-10-27 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04177004
The ClinicalTrials.gov registry entry for NCT04177004 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 952-participant average among 104 other Hematopoietic and Lymphoid Cell Neoplasm trials with a reported enrollment target (94% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hematopoietic and Lymphoid Cell Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04177004 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04177004 about?
NCT04177004 is a clinical study titled "Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant". 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 ...
What is the current status of trial NCT04177004?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2021-04-30. Estimated completion is 2026-10-27.
What conditions does trial NCT04177004 study?
This clinical trial studies the following conditions: Hematopoietic and Lymphoid Cell Neoplasm, Allogeneic Hematopoietic Stem Cell Transplant Recipient.
What interventions are being tested in trial NCT04177004?
The interventions under investigation include: Cyclophosphamide (DRUG), Etoposide (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Fractionated Stereotactic Radiation Therapy (RADIATION), Goat Milk (DRUG).
Who is sponsoring clinical trial NCT04177004?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04177004 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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