Status:
RECRUITING
PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis
Lead Sponsor:
Henry Ford Health System
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 grow...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04886726
Start Date
December 23 2021
End Date
November 30 2027
Last Update
February 10 2025
Active Locations (1)
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1
Henry Ford Hospital
Detroit, Michigan, United States, 48202