PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: uhCG/EGF.
- Who it may be relevant to
- Registry conditions: Graft Versus Host Disease. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- Drug uhCG/EGF
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
Primary outcome measures
- MTD [Time frame: day+30 post SCT]
- Incidence and severity of dose limiting toxicity (DLTs) [Time frame: day+30 post SCT]
Secondary outcome measures (4)
- acute GVHD [Time frame: till day +100 post SCT]
- Chronic GVHD [Time frame: one year post SCT]
- Overall survival [Time frame: one year post SCT]
- Disease free survival [Time frame: one year]
Eligibility criteria
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
- Donor specific antibodies
- Ejection fraction <40% or history of heart failure or cardiovascular disease
- history thrombosis or current thrombosis, family history of thrombosis, severe obesity, or thrombophilia.
- Previous history hormone responsive cancer
- history of seizure
- history of migraine or severe headache
- history of asthma
- history of uterine fibroid
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Henry Ford Hospital — Detroit
Identifiers
NCT: NCT04886726 · 14916