Graft Versus Host Disease
Conditions
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
Interventions
DRUGuhCG/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
Sponsors
Henry Ford Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MTD | day+30 post SCT | The maximum tolerated dose |
| Incidence and severity of dose limiting toxicity (DLTs) | day+30 post SCT | The overall incidence and severity of DLTs for uhCG/EGF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| acute GVHD | till day +100 post SCT | Cumulative incidence of acute GVHD |
| Chronic GVHD | one year post SCT | Cumulative incidence of chronic GVHD |
| Overall survival | one year post SCT | Death from any cause will be considered an event. Surviving patients will be censored at the time of last follow up. |
| Disease free survival | one year | Survival following allogeneic SCT without relapse or progression. Relapse or progression of disease, or death are considered events |
Countries
United States
Contacts
CONTACTshatha farhan
Outcome results
None listed