Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant
NCT ID: NCT04177004
Last Updated: 2025-12-15
Study Results
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Basic Information
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RECRUITING
PHASE1
53 participants
INTERVENTIONAL
2021-04-30
2026-10-27
Brief Summary
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Detailed Description
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I. To evaluate the safety and feasibility of human lysozyme goat milk (hLZ) treatment by assessing:
Ia: Type, frequency, severity, attribution, time course and duration of adverse events, including diarrhea, bloodstream/intestinal infections.
Ib. Patients' ability to drink the specified volume (250 ml 3 x/day) of hLZ during the treatment period.
SECONDARY OBJECTIVES:
I. To compare the incidence and severity of adverse events (AE) among hLZ-treated and untreated patients, including diarrhea, bloodstream infections and intestinal infections.
II. To obtain preliminary estimates of gut microbiome diversity, as assessed by the Simpson Index, in hLZ-treated/untreated patients.
III. To compare gut microbiome diversity among hLZ-treated/untreated patients. IV. To obtain a preliminary estimate of the possible association between gut microbiome diversity and bloodstream infections.
V. To obtain a preliminary estimate of the possible association between gut microbiome diversity and acute graft versus host disease (GVHD) cumulative incidence, including time to onset.
VI. To characterize and compare GVHD inflammatory biomarkers (presence, level) among hLZ-treated and untreated patients.
VII. To characterize and compare urinary uindoxyl sulfate, tryptophan and kynurenine levels between hLZ-treated and untreated patients.
IX. To obtain a preliminary estimate of gut microbiome diversity and calorie intake.
X. To estimate overall survival (OS) cumulative incidence (CI) chronic GVHD of relapse/progression, and non-relapse mortality (NRM) at 100 days (excluding chronic GVHD), 6 months, 1 year and 2 years.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP A:
CONDITIONING: Patients receive palifermin on days -10 to -8 and days 0 to 2, undergo fractionated total body irradiation (FTBI) on days -7 to -4, and receive cyclophosphamide on days -3 to -2 or etoposide on day -3 per City of Hope (COH) standard operating procedure (SOP) in the absence of disease progression or unacceptable toxicity.
HLZ: Patients receive human lysozyme goat milk orally (PO) three times daily (TID) on days -8 to 28 in the absence of disease progression or unacceptable toxicity.
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Beginning on day -2, patients receive tacrolimus and sirolimus daily per COH SOP in the absence of disease progression or unacceptable toxicity.
GROUP B:
CONDITIONING: Patients receive palifermin on days -10 to -8 and days 0 to 2 per COH SOP, undergo FTBI on days -7 to -4, and receive cyclophosphamide on days -3 to -2 or etoposide on day -3 per COH SOP in the absence of disease progression or unacceptable toxicity.
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Beginning on day -2, patients receive tacrolimus and sirolimus daily per COH SOP in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed up for up to 30-100 days and then up to 2 years after transplant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group A (conditioning, goat milk, transplant, prophylaxis)
CONDITIONING: Patients receive palifermin on days -10 to -8 and days 0 to 2, undergo FTBI on days -7 to -4, and receive cyclophosphamide on days -3 to -2 or etoposide on day -3 per COH SOP in the absence of disease progression or unacceptable toxicity.
HLZ: Patients receive human lysozyme goat milk PO TID on days -8 to 28 in the absence of disease progression or unacceptable toxicity.
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Beginning on day -2, patients receive tacrolimus and sirolimus daily per COH SOP in the absence of disease progression or unacceptable toxicity.
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allo-HCT
Cyclophosphamide
Given IV
Etoposide
Given IV
Fractionated Stereotactic Radiation Therapy
Undergo FTBI
Goat Milk
Given human lysozyme goat milk PO
Palifermin
Given IV
Sirolimus
Given PO
Tacrolimus
Given IV and PO
Group B (conditioning, transplant, prophylaxis)
CONDITIONING: Patients receive palifermin on days -10 to -8 and days 0 to 2 per COH SOP, undergo FTBI on days -7 to -4, and receive cyclophosphamide on days -3 to -2 or etoposide on day -3 per COH SOP in the absence of disease progression or unacceptable toxicity.
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Beginning on day -2, patients receive tacrolimus and sirolimus daily per COH SOP in the absence of disease progression or unacceptable toxicity.
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allo-HCT
Cyclophosphamide
Given IV
Etoposide
Given IV
Fractionated Stereotactic Radiation Therapy
Undergo FTBI
Palifermin
Given IV
Sirolimus
Given PO
Tacrolimus
Given IV and PO
Interventions
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Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allo-HCT
Cyclophosphamide
Given IV
Etoposide
Given IV
Fractionated Stereotactic Radiation Therapy
Undergo FTBI
Goat Milk
Given human lysozyme goat milk PO
Palifermin
Given IV
Sirolimus
Given PO
Tacrolimus
Given IV and PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Karamjeet S Sandhu
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2019-06454
Identifier Type: REGISTRY
Identifier Source: secondary_id
19214
Identifier Type: OTHER
Identifier Source: secondary_id
19214
Identifier Type: -
Identifier Source: org_study_id
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