PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Graft Versus Host Disease

Intervention / Treatment
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* Drug: uhCG/EGF


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTCY and uhCG/EGF<br>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 | Drug: uhCG/EGF<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MTD | The maximum tolerated dose | day+30 post SCT | 
| Incidence and severity of dose limiting toxicity (DLTs) | The overall incidence and severity of DLTs for uhCG/EGF | day+30 post SCT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute GVHD | Cumulative incidence of acute GVHD | till day +100 post SCT | 
| Chronic GVHD | Cumulative incidence of chronic GVHD | one year post SCT | 
| Overall survival | Death from any cause will be considered an event. Surviving patients will be censored at the time of last follow up. | one year post SCT | 
| Disease free survival | Survival following allogeneic SCT without relapse or progression. Relapse or progression of disease, or death are considered events | one year |