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

NCT04177004 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-04-15

No results posted yet for this 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

  • Allogeneic Hematopoietic Stem Cell Transplant Recipient
  • Hematopoietic and Lymphoid Cell Neoplasm

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allo-HCT

DRUG

Cyclophosphamide

Given IV

DRUG

Etoposide

Given IV

RADIATION

Fractionated Stereotactic Radiation Therapy

Undergo FTBI

DRUG

Goat Milk

Given human lysozyme goat milk PO

BIOLOGICAL

Palifermin

Given IV

DRUG

Sirolimus

Given PO

DRUG

Tacrolimus

Given IV and PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Karamjeet S Sandhu · City of Hope Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2026-10-27
Completion
2026-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04177004 on ClinicalTrials.gov