PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

Graft Versus Host Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04886726
• Other study ID #: 14916
• Status: Recruiting
• Phase: Phase 1
• Start date: December 23, 2021
• Est. completion date: November 30, 2027

Study information

• Verified date: January 2024
• Source: Henry Ford Health System
• Contact: shatha farhan
• Phone: 3137133910
• Email: sfarhan1[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: November 30, 2027
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• uhCG/EGF
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

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD	The maximum tolerated dose	day+30 post SCT
Primary	Incidence and severity of dose limiting toxicity (DLTs)	The overall incidence and severity of DLTs for uhCG/EGF	day+30 post SCT
Secondary	acute GVHD	Cumulative incidence of acute GVHD	till day +100 post SCT
Secondary	Chronic GVHD	Cumulative incidence of chronic GVHD	one year post SCT
Secondary	Overall survival	Death from any cause will be considered an event. Surviving patients will be censored at the time of last follow up.	one year post SCT
Secondary	Disease free survival	Survival following allogeneic SCT without relapse or progression. Relapse or progression of disease, or death are considered events	one year