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

Northside Hospital, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Hematopoietic Cell Transplant; Hematologic Disease and Disorders

Treatments: Drug: Cyclophosphamide; Drug: Mycofenolate mofetil; Drug: Tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT06828796

NSH 1420

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Tacrolimus + MMF + Post-Transplant Cyclophosphamide

Experimental group

Description:

Cyclophosphamide 50mg/kg/d Days +3 and +4 after transplant Tacrolimus Day -1 to Day +90 or Day +180 after transplant MMF 15mg/kg PO TID Day 0 to Day +35

Treatment:

Drug: Tacrolimus

Drug: Mycofenolate mofetil

Drug: Cyclophosphamide