PTCY + uhCG/EGF for Graft-versus-Host Disease Prophylaxis
Trial Summary
What is the purpose of this trial?
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
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment PTCY + uhCG/EGF for preventing graft-versus-host disease?
Research shows that post-transplant cyclophosphamide (PTCy) is effective in reducing the incidence of severe acute graft-versus-host disease (GVHD) and improving survival outcomes in patients undergoing hematopoietic cell transplantation. Combining PTCy with other agents like anti-thymocyte globulin (ATG) has been shown to further reduce the risk of GVHD without increasing infection or relapse risks.12345
Is the combination of PTCY and uhCG/EGF safe for humans?
How is the treatment PTCY + uhCG/EGF for graft-versus-host disease different from other treatments?
The treatment PTCY + uhCG/EGF is unique because it combines post-transplant cyclophosphamide (PTCY) with a novel component, uhCG/EGF (Pregnyl), which is not typically used in standard graft-versus-host disease (GvHD) prophylaxis. This combination may offer a new approach by potentially enhancing the effectiveness of PTCY in preventing GvHD, although specific details about the role of uhCG/EGF in this context are not well-documented in the available research.12468
Research Team
Eligibility Criteria
This trial is for adults aged 18-70 with certain blood cancers needing a stem cell transplant but without matched donors. They must be mostly healthy, with good organ function and performance status. Women of childbearing age need a negative pregnancy test and must use birth control during the study.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
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
Follow-up
Participants are monitored for safety and effectiveness after treatment, including incidence of acute and chronic GVHD
Treatment Details
Interventions
- uhCG/EGF (Graft Versus Host Disease Prophylaxis)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry Ford Health System
Lead Sponsor