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

Northside Hospital, Inc.

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

Age range: 18–80 years
Sex: All
Healthy volunteers: No

Detailed criteria

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…

Interventions

Drug
Tacrolimus
Begins Day -1 and continues to Day +90 or Day +180 after transplant
Drug
Cyclophosphamide
Given Days +3 and +4 after transplant
Drug
Mycofenolate mofetil
Given Day 0 to Day +35 after transplant

Location

Northside Hospital
Atlanta, Georgia
caitlin.guzowski@northside.com 404-851-8523

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

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions