PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis (NCT04886726) | Clinical Trial Compass
RecruitingPhase 1
PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis
United States18 participantsStarted 2021-12-23
Plain-language 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
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
What they're measuring
1
MTD
Timeframe: day+30 post SCT
2
Incidence and severity of dose limiting toxicity (DLTs)