RecruitingPhase 2NCT06828796

Early Use of Tacrolimus in HLA-Mismatched Haploidentical Allogeneic Hematopoietic Transplantation With Post-Transplant Cyclophosphamide

Sponsor

Northside Hospital, Inc.

Enrollment

20 participants

Start Date

Jul 3, 2025

Study Type

INTERVENTIONAL

Conditions

Hematologic Disease and Disorders Hematopoietic Cell Transplant

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria6

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