PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

Recruiting now · Phase 1

Conditions studied: Graft Versus Host Disease

In brief

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

Key facts

Study ID

NCT04886726

Run by

Henry Ford Health System

People needed

18

Starts

2021-12-23

Expected to finish

2028-11-30

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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