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

Recruiting now · Phase 2

Conditions studied: Hematologic Disease and Disorders, Hematopoietic Cell Transplant

In brief

To evalute the safety and efficacy in reducing Cytokine Release Syndrome after hematopoietic stem cell transplantation by introducing immunosuppression earlier in the transplant process

Key facts

Study ID: NCT06828796
Run by: Northside Hospital, Inc.
People needed: 20
Starts: 2025-07-03
Expected to finish: 2028-06-30
Last updated by the study team: 2026-04-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Northside Hospital — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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