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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNorthside Hospital, Inc.

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Tacrolimus
  • Cyclophosphamide
  • Mycofenolate mofetil

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators