PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

Phase 1

Recruiting

• Conditions: Graft Versus Host Disease
• Interventions: Drug: uhCG/EGF

• Registration Number: NCT04886726
• Lead Sponsor: Henry Ford Health System

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-14
• Study Start: 2021-12-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PTCY and uhCG/EGF	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 Measures

Name	Time	Method
Incidence and severity of dose limiting toxicity (DLTs)	day+30 post SCT	The overall incidence and severity of DLTs for uhCG/EGF
MTD	day+30 post SCT	The maximum tolerated dose

Secondary Outcome Measures

Name	Time	Method
acute GVHD	till day +100 post SCT	Cumulative incidence of acute GVHD
Chronic GVHD	one year post SCT	Cumulative incidence of chronic GVHD
Overall survival	one year post SCT	Death from any cause will be considered an event. Surviving patients will be censored at the time of last follow up.
Disease free survival	one year	Survival following allogeneic SCT without relapse or progression. Relapse or progression of disease, or death are considered events

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States