Combining post-transplant cyclophosphamide with uhCG/EGF for preventing Graft Versus Host Disease

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

This study is testing if a new combination of medications can help prevent Graft Versus Host Disease in patients with blood cancers who are getting stem cell transplants from unrelated donors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Henry Ford Health System (Academic / other)
• Drugs / interventions: cyclophosphamide
• Locations: 1 site (Detroit, Michigan)
• Trial ID: NCT04886726 on ClinicalTrials.gov

What this trial studies

This Phase I study aims to evaluate the feasibility and safety of using a combination of post-transplant cyclophosphamide and urinary-derived human chorionic gonadotropin and epidermal growth factor (uhCG/EGF) as a prophylactic measure against Graft Versus Host Disease (GVHD) in patients undergoing stem cell transplantation. The study will also assess the incidence of acute and chronic GVHD, as well as progression-free and overall survival rates among participants. The approach focuses on patients with hematologic malignancies who are receiving allogeneic stem cell transplants from mismatched unrelated donors (MMUDs).

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 with hematologic malignancies requiring allogeneic stem cell transplantation and who do not have minimal residual disease or matched related/unrelated donors.

Not a fit: Patients with active viral hepatitis, HIV, or those with a history of serious chronic conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of GVHD in stem cell transplant patients, improving their overall survival and quality of life.

How similar studies have performed: While this specific combination has not been widely tested, similar approaches in GVHD prophylaxis have shown promise in other studies.

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

Where this trial is running

Detroit, Michigan

• Henry Ford Hospital — Detroit, Michigan, United States (Recruiting)

Study contacts

• Study coordinator: shatha farhan

Conditions Graft Versus Host Disease