NCT04886726 PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis
| NCT ID | NCT04886726 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Henry Ford Health System |
| Condition | Graft Versus Host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2021-12-23 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2021-12-23 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04886726 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Graft Versus Host Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04886726 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04886726 currently recruiting?
Yes, NCT04886726 is actively recruiting participants. Contact the research team at sfarhan1@hfhs.org for enrollment information.
Where is the NCT04886726 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT04886726 clinical trial?
NCT04886726 is sponsored by Henry Ford Health System. The trial plans to enroll 18 participants.