NCT06828796PHASE2Recruiting
Early Use of Tacrolimus in HLA-Mismatched Haploidentical Allogeneic Hematopoietic Transplantation With Post-Transplant Cyclophosphamide
Northside Hospital, Inc.
Start Date
7/3/2025
Completion Date
6/30/2028
Summary
To evalute the safety and efficacy in reducing Cytokine Release Syndrome after hematopoietic stem cell transplantation by introducing immunosuppression earlier in the transplant process
Eligibility Criteria
Age Range: 18 years to 80 years
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
Interventions
DRUG
Tacrolimus
DRUG
Cyclophosphamide
DRUG
Mycofenolate mofetil
Conditions
Hematologic Disease and DisordersHematopoietic Cell Transplant
Locations
Northside Hospital
Atlanta, Georgia 30342
United States