PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

NCT04886726 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 14916
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• MTD

  The maximum tolerated dose

  day+30 post SCT

• Incidence and severity of dose limiting toxicity (DLTs)

  The overall incidence and severity of DLTs for uhCG/EGF

  day+30 post SCT

Secondary Outcomes (4)

• acute GVHD

  till day +100 post SCT

• Chronic GVHD

  one year post SCT

• Overall survival

  one year post SCT

• Disease free survival

  one year

Study Arms (1)

PTCY and uhCG/EGF

EXPERIMENTAL

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

Drug: uhCG/EGF

Interventions

uhCG/EGF 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

PTCY and uhCG/EGF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hematologic malignancy who have the indication for Allogeneic SCT and have no MRD or MUD.
• Age 18-70 years old
• Performance score of at least 80% by Karnofsky
• Adequate kidney and liver function as demonstrated by:
• Creatinine clearance should be \>60 ml/min
• Total Bilirubin \<1.5, ALT/AST/Alk Phos \< 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
• 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.
• Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.

You may not qualify if:

• Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
• Active or prior CNS leukemia, unless in complete remission for at least 2 months.
• History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
• Uncontrolled infection
• Donor specific antibodies
• Ejection fraction \<40% or history of heart failure or cardiovascular disease
• history thrombosis or current thrombosis, family history of thrombosis, severe obesity, or thrombophilia.
• Previous history hormone responsive cancer
• history of seizure
• history of migraine or severe headache
• history of asthma
• history of uterine fibroid

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

shatha farhan

CONTACT

3137133910; sfarhan1@hfhs.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 14, 2021
• Study Start: December 23, 2021
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (1)