PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

Henry Ford Health

Status and phase: Enrolling; Phase 1

Conditions: Graft Versus Host Disease

Treatments: Drug: uhCG/EGF

Study type: Interventional

Funder types: Other

Identifiers

NCT04886726

14916

Details and patient eligibility

About

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

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion 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.

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

PTCY and uhCG/EGF

Experimental group

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

Treatment:

Drug: uhCG/EGF