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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• Henry Ford Hospital
  Detroit, Michigan, United States Recruiting

Study contacts

• Study coordinator: shatha farhan
• Email: sfarhan1@hfhs.org
• Phone: 3137133910

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This trial will test whether adding emapalumab to post‑transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil can prevent graft‑versus‑host disease in adults with AML or MDS receiving a reduced‑intensity donor stem cell transplant.

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• Vedolizumab with post-transplant cyclophosphamide and short-course tacrolimus to prevent graft-versus-host disease after reduced-intensity allogeneic stem cell transplant

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  Recruiting Phase 2 City of Hope Medical Center · Duarte, California · NCT06815003

• Reduced versus standard dose post-transplant cyclophosphamide with tacrolimus and a single low-dose ATG to prevent GVHD after alternative-donor peripheral stem cell transplant

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  Recruiting Phase 3 Shanghai Jiao Tong University School of Medicine · Shanghai, Shanghai Municipality · NCT06705062

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• Using Ruxolitinib to prevent complications after haploidentical stem cell transplants

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.