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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.

Compiled by PlainTrial · August 8, 2026

Recruiting
Registry status: Phase 1
Development phase: 53
Enrollment target: 1
Study location

NCT04177004: Recruiting Phase 1 study of Hematopoietic and Lymphoid Cell Neoplasm and Allogeneic Hematopoietic Stem Cell Transplant Recipient, sponsored by City of Hope Medical Center.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

In the safety lead-in phase, we are going to investigate if a patient can drink the daily amount of 750 ml of hLZ.. The actual volume of milk consumed per day will be measured using graduated cups and recorded on daily basis. To calculate the average daily consumption, total volume of hLZ consumed by each patient for the whole inpatient stay will be divided by the total number of inpatient stay for that patient. Tolerable dose established based on the average daily hLZ consumption in the first

Conditions Studied

Hematopoietic and Lymphoid Cell Neoplasm Allogeneic Hematopoietic Stem Cell Transplant Recipient

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

City of Hope Medical Center

582 total trials

What NCT04177004 shows while recruiting

NCT04177004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 952-participant average among 104 other Hematopoietic and Lymphoid Cell Neoplasm trials with a reported enrollment target (94% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Hematopoietic and Lymphoid Cell Neoplasm

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04177004's enrollment target sits among peer trials

53 60th of 104 higher than 44 of 104 other Hematopoietic and Lymphoid Cell Neoplasm trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hematopoietic and Lymphoid Cell Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04177004, the US trial registry maintained by the National Library of Medicine. NCT04177004 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.