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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

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Conditions

Hematologic Disease and DisordersHematopoietic Cell Transplant

Locations

Northside Hospital

Atlanta, Georgia 30342

United States