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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTCY and uhCG/EGF | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| uhCG/EGF | Drug | 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 |
|
| 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 |
| 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 |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| shatha farhan | Contact | 3137133910 | sfarhan1@hfhs.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Recruiting | Detroit | Michigan | 48202 | United States |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| 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 |