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

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

Status
Active
Cancer Type
Trial Phase
Phase II
Eligibility
, Male and Female
Study Type
NCT ID
NCT06828796
Protocol IDs
NSH 1420 (primary)
Study Sponsor
Northside Hospital
NCI Full Details

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

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

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523


Doctors:

Melhem Solh MD
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