MedTrace Logo

Human Lysozyme Goat Milk in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant

NCT03531281 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-12-07

No results posted yet for this study

Summary

This randomized pilot phase I trial studies the side effects of human lysozyme goat milk in treating patients with blood cancer undergoing a donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving human lysozyme goat milk to patients undergoing a donor stem cell transplant may stop this from happening.

Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Hematopoietic Cell Transplantation Recipient

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allo-HCT

DRUG

Cyclophosphamide

Given IV

DRUG

Etoposide

Given IV

DRUG

Goat Milk

Given human lysozyme goat milk PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Palifermin

Given IV

DRUG

Sirolimus

Given PO

DRUG

Tacrolimus

Given IV and PO

RADIATION

Total-Body Irradiation

Undergo FTBI

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Karamjeet Sandhu · City of Hope Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-30
Primary Completion
2022-12-30
Completion
2022-12-30
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 NCT03531281 on ClinicalTrials.gov