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Human Lysozyme Goat Milk for Blood Cancer Post-Transplant Care

Phase 1

Recruiting

Led By Karamjeet S Sandhu

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 years

Awards & highlights

Approved for 20 Other Conditions

No Placebo-Only Group

Summary

This trial is testing the side effects of human lysozyme goat milk in preventing graft versus host disease for patients with blood cancer who are undergoing a donor stem cell transplant.

Who is the study for?

This trial is for blood cancer patients undergoing donor stem cell transplants. Participants must understand and consent to the study, have a performance status of >=60, normal liver function tests, agree to use birth control, and be free from other active cancers or infections. They should not be lactose intolerant or allergic to milk products.

What is being tested?

The trial is testing human lysozyme goat milk's ability to prevent graft versus host disease post-transplant. The milk comes from genetically modified goats producing human lysozyme—an enzyme that supports gut health by promoting beneficial bacteria growth.

What are the potential side effects?

Potential side effects may include digestive issues due to intolerance to components in the goat milk. Since this is a phase I trial primarily assessing safety, detailed side effect profiles will be studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am undergoing a specific radiation therapy before a bone marrow transplant.

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I am receiving a stem cell transplant from a donor who is a complete match.

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I can care for myself but may need occasional help.

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My kidneys are functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I understand the study's details and the risks and benefits of participating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events

Patients' ability to drink the specified daily amount of 750 ml human lysozyme goat milk (hLZ)

Unacceptable toxicity

+1 more

Secondary study objectives

CI of NRM

CI of acute graft versus host disease (aGVHD)

CI of non-relapse mortality (NRM)

+6 more

Side effects data

From 2019 Phase 2 trial • 77 Patients • NCT01251575

Hypoxia

Febrile neutropenia

Acute kidney injury

Blood bilirubin increased

Diarrhea

Creatinine increased

Sepsis

Hypotension

Left ventricular systolic dysfunction

Bronchopulmonary hemorrhage

Chronic kidney disease

Thromboembolic event

Lung infection

Atrial fibrillation

Atrial flutter

Hemolysis

Hemolytic uremic syndrome

Ejection fraction decreased

Encephalitis infection

Gastric hemorrhage

Gastritis

Heart failure

Mucositis oral

Multi-organ failure

Myalgia

Pleural effusion

Respiratory failure

Small intestine infection

Syncope

Treatment related secondary malignancy

Typhlitis

Fever

Paroxysmal atrial tachycardia

Ascites

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Fludarabine, Transplant, Immunosuppression)

Awards & Highlights

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group A (conditioning, goat milk, transplant, prophylaxis)Experimental Treatment8 Interventions

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.

Group II: Group B (conditioning, transplant, prophylaxis)Active Control7 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palifermin

FDA approved

Cyclophosphamide

FDA approved

Etoposide

FDA approved

Allogeneic Hematopoietic Stem Cell Transplantation

2012