Could goat milk help prevent a deadly transplant side effect?
NCT ID NCT04177004
First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times
Summary
This early-phase study tests whether drinking milk from genetically engineered goats (which produce a human enzyme found in breast milk) can reduce the risk of graft versus host disease—a serious immune reaction—in blood cancer patients receiving a donor stem cell transplant. About 52 participants will drink the milk daily during their hospital stay to see if it is safe and tolerable. The goal is to find a new way to protect patients without using extra drugs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
52 people
The number who actually took part.
- Started
-
Apr 2021
- Expected to finish
-
Oct 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Willingness to be followed for the planned duration of the trial (2 years) * All subjects must have the ability to understand and the willingness to sign a written informed consent * Karnofsky performance status \>= 60 per COH SOP * Patients must be undergoing allogeneic hematopoietic stem cell transplantation (alloHCT) for hematologic malignancies from matched related or matched unrelated donors with 8/8 (A, B, C, DRB 1) high resolution human leukocyte antigen (HLA) donor allele matching * Patients must be receiving a fractionated total body radiation (FTBI) based- myeloablative conditioning regimen; (acceptable conditioning regimens include total body irradiation \[TBI\] + cyclophosphamide or TBI + etoposide) * Ejection fraction measured by echocardiogram or multi gated acquisition scan (MUGA) \> 50% * Diffusing capacity for carbon monoxide (DLCO) adjusted for hemoglobin or forced vital capacity (FVC) \> 50% predicted * Total serum bilirubin \< 2 times upper limit of normal * Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =\< 2.5 x the upper normal limit * Alkaline phosphatase =\< 2.5 x the upper normal limit * Measured creatinine clearance more than 60 mL/min * Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through 90 days after the last dose of protocol therapy * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this pilot study. A legal guardian may substitute for the research participant * Research participants receiving any other investigational agents * Research participants with presence of other active malignancy within 2 years of study entry. Participants with history of prior malignancy treated with curative intent who achieved complete remission (CR) more than 2 years before study entry are eligible. This exclusion rule does not apply to non-melanoma skin tumors and in-situ cervical cancer * Research participants having any uncontrolled illness including ongoing or active infection. Research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures, or radiological evidence of infections * Refusing to use contraception up to 90 days post-HCT * Pregnant and/or breast feeding if a female recipient * Lactose intolerance or intolerance to milk products * In the opinion of the principal investigator (PI), the participant has a condition that will preclude them from complying with study treatment
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Allogeneic hematopoietic stem cell transplant recipient are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
City of Hope Medical Center
Duarte, California, 91010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a phone app help childhood cancer survivors keep track of their health?
- Can a new PET tracer reveal hidden immune clues in tumors?
- A hug in a blanket: could deep pressure calm cancer infusion anxiety?
- Could a strong social circle turn back the clock for transplant survivors?
- Blood test may one day personalize drug dosing after stem cell transplants
- Can a Two-Step stem cell transplant tame Graft-Versus-Host disease?