Recruiting
Phase 1

PTCY with uhCG/EGF

Sponsor:

Henry Ford Health System

Code:

NCT04886726

Conditions

Graft Versus Host Disease

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

uhCG/EGF

Study Details

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 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

Study ID

NCT04886726

Start date

Dec 23, 2021

Status verified date

Feb, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PTCY and 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

Interventions

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

Primary outcome measure

  • MTD [ Time Frame: day+30 post SCT ]
  • Incidence and severity of dose limiting toxicity (DLTs) [ Time Frame: day+30 post SCT ]

Central Contacts and Locations

Central contacts

Locations

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

More Information

Sponsor

Henry Ford Health System

Last update posted

Feb 24, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-02-24.