Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am undergoing a specific radiation therapy before a bone marrow transplant.
Select...
I am receiving a stem cell transplant from a donor who is a complete match.
Select...
I can care for myself but may need occasional help.
Select...
My kidneys are functioning well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
Patients' ability to drink the specified daily amount of 750 ml human lysozyme goat milk (hLZ)
Unacceptable toxicity
+1 moreSecondary outcome measures
CI of NRM
CI of acute graft versus host disease (aGVHD)
CI of non-relapse mortality (NRM)
+6 moreSide effects data
From 2019 Phase 2 trial • 77 Patients • NCT012515755%
Hypoxia
5%
Febrile neutropenia
5%
Acute kidney injury
4%
Blood bilirubin increased
4%
Diarrhea
4%
Creatinine increased
4%
Sepsis
3%
Hypotension
3%
Left ventricular systolic dysfunction
3%
Bronchopulmonary hemorrhage
3%
Chronic kidney disease
3%
Thromboembolic event
3%
Lung infection
1%
Atrial fibrillation
1%
Atrial flutter
1%
Hemolysis
1%
Hemolytic uremic syndrome
1%
Ejection fraction decreased
1%
Encephalitis infection
1%
Gastric hemorrhage
1%
Gastritis
1%
Heart failure
1%
Mucositis oral
1%
Multi-organ failure
1%
Myalgia
1%
Pleural effusion
1%
Respiratory failure
1%
Small intestine infection
1%
Syncope
1%
Treatment related secondary malignancy
1%
Typhlitis
1%
Fever
1%
Paroxysmal atrial tachycardia
1%
Ascites
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Fludarabine, Transplant, Immunosuppression)
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
Completed Phase 2
~1200
Sirolimus
FDA approved
Tacrolimus
FDA approved
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,424 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,969 Total Patients Enrolled
Karamjeet S SandhuPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
41 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not allowed to be taking any other experimental or investigational drugs as part of another study.I am undergoing a specific radiation therapy before a bone marrow transplant.I am receiving a stem cell transplant from a donor who is a complete match.I am capable of having children and have not been surgically sterilized.I can care for myself but may need occasional help.I have not had any active cancer except for non-melanoma skin cancer or in-situ cervical cancer in the past 2 years.I do not have any uncontrolled illnesses or active infections, including hepatitis B or C, and I am not HIV positive.My kidneys are functioning well.You are unable to digest lactose or have trouble with dairy products.I understand the study's details and the risks and benefits of participating.
Research Study Groups:
This trial has the following groups:- Group 1: Group B (conditioning, transplant, prophylaxis)
- Group 2: Group A (conditioning, goat milk, transplant, prophylaxis)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have there been any other studies investigating the effects of Allogeneic Hematopoietic Stem Cell Transplantation?
"Currently, 1170 clinical studies are live which examine Allogeneic Hematopoietic Stem Cell Transplantation with 230 trials currently in Phase 3. Philadelphia, Pennsylvania is a hub for this type of research but there remain 37,639 locations throughout the world where these trails are taking place."
Answered by AI
To what extent can Allogeneic Hematopoietic Stem Cell Transplantation present risks to individuals?
"Our team at Power evaluated the safety of Allogeneic Hematopoietic Stem Cell Transplantation to be a 1 due to this trial's Phase 1 designation, indicating that there is only sparse evidence regarding efficacy and safety."
Answered by AI
How many subjects are being observed in this clinical experiment?
"Affirmative. The information on clinicaltrials.gov displays that this investigation is still recruiting patients. It was first released on April 30th 2021 and has been updated most recently as of August 15th 2022, with the aim to enlist 36 individuals at a single site."
Answered by AI
Are there still openings for enrolment in this clinical experiment?
"Affirmative. According to the details hosted on clinicaltrials.gov, this medical research project is actively seeking subjects and was first published on April 30th 2021 with a recent update occurring August 15th 2022. The study necessitates the recruitment of 36 patients from one location."
Answered by AI
In what medical circumstances is Allogeneic Hematopoietic Stem Cell Transplantation typically employed?
"Allogeneic Hematopoietic Stem Cell Transplantation is the go-to treatment for leukemia, but there are many other malignancies that can be addressed with it such as prostate and lung cancer (including small cell variants)."
Answered by AI
What are the desired outcomes of this clinical exploration?
"This clinical trial aims to identify unacceptable levels of toxicity over the course of up to 28 days post-transplant or date of discharge. Secondary outcomes include determining CI incidence curves for chronic GVHD, which is scored according to NIH Consensus Staging, and NRM (non-relapse mortality), with both being evaluated using a method described by Gooley et al (1999)."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger