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

Phase 2

Not yet recruiting

• Conditions: Hematologic Disease and Disorders; Hematopoietic Cell Transplant
• Interventions: Drug: Tacrolimus; Drug: Cyclophosphamide; Drug: Mycofenolate mofetil

• Registration Number: NCT06828796
• Lead Sponsor: Northside Hospital, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-11
• Study First Posted: 2025-02-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Study Start: 2025-06
• Primary Completion: 2027-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tacrolimus + MMF + Post-Transplant Cyclophosphamide	Tacrolimus	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
Tacrolimus + MMF + Post-Transplant Cyclophosphamide	Cyclophosphamide	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
Tacrolimus + MMF + Post-Transplant Cyclophosphamide	Mycofenolate mofetil	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

Primary Outcome Measures

Name	Time	Method
Efficacy in preventing CRS post transplant	30 days	Evaluate the incidence of CRS during the first 5 days following stem cell transplant by recording signs and symptoms based on CTCAE v5.0.

Secondary Outcome Measures

Name	Time	Method
Severity of CRS after stem cell transplant	30 days	Record incidence of CRS by grading signs and symptoms using the CTCAE v5.0, the day of onset of CRS, the duration of CRS, and admissions to the hospital for these events
Safety of administering early immunosuppression	1 year	Record incidence of chronic graft-versus-host disease at 1 year by using the NIH Grading Consensus system

Trial Locations

Locations (1)

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States