PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

Description

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

Conditions

Graft Versus Host Disease

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Study Overview

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Study Details

Study overview

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

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

PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

Condition
Graft Versus Host Disease
Intervention / Treatment

-

Contacts and Locations

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patients with hematologic malignancy who have the indication for Allogeneic SCT and have no MRD or MUD.
  • 2. Age 18-70 years old
  • 3. Performance score of at least 80% by Karnofsky
  • 4. Adequate kidney and liver function as demonstrated by:
  • 1. Creatinine clearance should be \>60 ml/min
  • 2. Total Bilirubin \<1.5, ALT/AST/Alk Phos \< 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
  • 5. 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.
  • 6. Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
  • 1. Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
  • 2. Active or prior CNS leukemia, unless in complete remission for at least 2 months.
  • 3. History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
  • 4. Uncontrolled infection
  • 5. Donor specific antibodies
  • 6. Ejection fraction \<40% or history of heart failure or cardiovascular disease
  • 7. history thrombosis or current thrombosis, family history of thrombosis, severe obesity, or thrombophilia.
  • 8. Previous history hormone responsive cancer
  • 9. history of seizure
  • 10. history of migraine or severe headache
  • 11. history of asthma
  • 12. history of uterine fibroid

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Henry Ford Health System,

Study Record Dates

2027-11-30