PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

NCT ID: NCT04886726

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-23
• Study Completion Date: 2027-11-30

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

uhCG/EGF

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Shatha Farhan

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henry Ford Hospital

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

shatha farhan

Role: CONTACT

sfarhan1@hfhs.org

3137133910

Facility Contacts

shatha farhan

Role: primary

sfarhan1@hfhs.org

313-713-3910

Other Identifiers

14916

Identifier Type: -

Identifier Source: org_study_id