Early Use of Tacrolimus in HLA-Mismatched Haploidentical Allogeneic Hematopoietic Transplantation With Post-Transplant Cyclophosphamide
Purpose
To evalute the safety and efficacy in reducing Cytokine Release Syndrome after hematopoietic stem cell transplantation by introducing immunosuppression earlier in the transplant process
Conditions
- Hematologic Disease and Disorders
- Hematopoietic Cell Transplant
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Availability of a 5/10-8/10 mismatched (HLA-A, B, DR) haploidentical related donor with a negative HLA cross-match in the host vs. graft direction and willing to provide peripheral blood stem cells - Karnofsky status >/= 70% - Hematologic malignancy requiring allogeneic transplantation - First allogeneic transplant only. Prior autologous transplant is allowed.
Exclusion Criteria
- Poor cardiac function: LVEF <40% - Poor pulmonary function: FEV1 and FVC <50% predicted - Poor liver function: bilirubin >/= 3mg/dL (not due to hemolysis, Gilbert's or primary malignancy) - Poor renal function: Creatinine >/= 2mg/dL or creatinine clearance (calculated or measured creatinine clearance is permitted) <40mL/min based on Traditional Cockcroft-Gault formula - Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception - Patients who have any debilitating medical or psychiatric illness that would preclude their giving informed consent or their receiving optimal treatment and follow up
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tacrolimus + MMF + Post-Transplant Cyclophosphamide |
Cyclophosphamide 50mg/kg/d Days +3 and +4 after transplant Tacrolimus Day -1 to Day +90 or Day +180 after transplant MMF 15mg/kg PO TID Day 0 to Day +35 |
|
Recruiting Locations
Northside Hospital
Atlanta, Georgia 30342
Atlanta, Georgia 30342
More Details
- Status
- Recruiting
- Sponsor
- Northside Hospital, Inc.