PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis
Primary Purpose
Graft Versus Host Disease
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
uhCG/EGF
Sponsored by
About this trial
This is an interventional prevention trial for Graft Versus Host Disease
Eligibility Criteria
Inclusion Criteria:
- Patients with hematologic malignancy who have the indication for Allogeneic SCT and have no MRD or MUD.
- Age 18-70 years old
- Performance score of at least 80% by Karnofsky
Adequate kidney and liver function as demonstrated by:
- Creatinine clearance should be >60 ml/min
- Total Bilirubin <1.5, ALT/AST/Alk Phos < 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
- Negative Beta HCG test in a woman with childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of childbearing potential must be willing to use an effective contraceptive measure while on study.
- Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
Exclusion Criteria:
- Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
- Active or prior CNS leukemia, unless in complete remission for at least 2 months.
- History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
- Uncontrolled infection
- Donor specific antibodies
- Ejection fraction <40% or history of heart failure or cardiovascular disease
- history thrombosis or current thrombosis, family history of thrombosis, severe obesity, or thrombophilia.
- Previous history hormone responsive cancer
- history of seizure
- history of migraine or severe headache
- history of asthma
- history of uterine fibroid
Sites / Locations
- Henry Ford HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PTCY and uhCG/EGF
Arm Description
PTCY for 2 doses on day +3 and +4 after stem cell transplant followed by uhCG/EGF subcutaneously on day +7, +9 and +11 post stem cell transplant
Outcomes
Primary Outcome Measures
MTD
The maximum tolerated dose
Incidence and severity of dose limiting toxicity (DLTs)
The overall incidence and severity of DLTs for uhCG/EGF
Secondary Outcome Measures
acute GVHD
Cumulative incidence of acute GVHD
Chronic GVHD
Cumulative incidence of chronic GVHD
Overall survival
Death from any cause will be considered an event. Surviving patients will be censored at the time of last follow up.
Disease free survival
Survival following allogeneic SCT without relapse or progression. Relapse or progression of disease, or death are considered events
Full Information
NCT ID
NCT04886726
First Posted
May 5, 2021
Last Updated
December 27, 2022
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT04886726
Brief Title
PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis
Official Title
Post-transplant Cyclophosphamide and Urinary-derived Human Chorionic Gonadotropin and Epidermal Growth Factor (uhCG/EGF) as Graft Versus Host Disease Prophylaxis for Mismatched Unrelated Donor Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 23, 2021 (Actual)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
So this a Phase I study with primary objective to determine the feasibility and safety of combining post-transplant cyclophosphamide and urinary-derived human chorionic gonadotropin and epidermal growth factor (uhCG/EGF) as graft versus host disease prophylaxis in stem cell transplant with MMUDs Secondary objectives are to determine the incidence acute and chronic GVHD, progression-free survival , and overall survival
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PTCY and uhCG/EGF
Arm Type
Experimental
Arm Description
PTCY for 2 doses on day +3 and +4 after stem cell transplant followed by uhCG/EGF subcutaneously on day +7, +9 and +11 post stem cell transplant
Intervention Type
Drug
Intervention Name(s)
uhCG/EGF
Intervention Description
PTCY for 2 doses on day +3 and +4 after stem cell transplant followed by uhCG/EGF subcutaneously on day +7, +9 and +11 post stem cell transplant
Primary Outcome Measure Information:
Title
MTD
Description
The maximum tolerated dose
Time Frame
day+30 post SCT
Title
Incidence and severity of dose limiting toxicity (DLTs)
Description
The overall incidence and severity of DLTs for uhCG/EGF
Time Frame
day+30 post SCT
Secondary Outcome Measure Information:
Title
acute GVHD
Description
Cumulative incidence of acute GVHD
Time Frame
till day +100 post SCT
Title
Chronic GVHD
Description
Cumulative incidence of chronic GVHD
Time Frame
one year post SCT
Title
Overall survival
Description
Death from any cause will be considered an event. Surviving patients will be censored at the time of last follow up.
Time Frame
one year post SCT
Title
Disease free survival
Description
Survival following allogeneic SCT without relapse or progression. Relapse or progression of disease, or death are considered events
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with hematologic malignancy who have the indication for Allogeneic SCT and have no MRD or MUD.
Age 18-70 years old
Performance score of at least 80% by Karnofsky
Adequate kidney and liver function as demonstrated by:
Creatinine clearance should be >60 ml/min
Total Bilirubin <1.5, ALT/AST/Alk Phos < 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
Negative Beta HCG test in a woman with childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of childbearing potential must be willing to use an effective contraceptive measure while on study.
Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
Exclusion Criteria:
Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
Active or prior CNS leukemia, unless in complete remission for at least 2 months.
History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
Uncontrolled infection
Donor specific antibodies
Ejection fraction <40% or history of heart failure or cardiovascular disease
history thrombosis or current thrombosis, family history of thrombosis, severe obesity, or thrombophilia.
Previous history hormone responsive cancer
history of seizure
history of migraine or severe headache
history of asthma
history of uterine fibroid
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shatha farhan
Phone
3137133910
Email
sfarhan1@hfhs.org
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shatha farhan
Phone
313-713-3910
Email
sfarhan1@hfhs.org
12. IPD Sharing Statement
Learn more about this trial
PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis
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