Dysautonomia International

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

Purpose

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

Conditions

Hematologic Disease and Disorders
Hematopoietic Cell Transplant

Eligibility

Eligible Ages: Between 18 Years and 80 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Phase: Phase 2
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Tacrolimus + MMF + Post-Transplant 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	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

Recruiting Locations

Northside Hospital
Atlanta, Georgia 30342

Contact:
Caitlin Guzowski, MBA, MHA, CCRC
404-851-8523
caitlin.guzowski@northside.com

More Details

Status: Recruiting
Sponsor: Northside Hospital, Inc.

Study Contact

Melh Solh, MD
404-255-1930
msolh@bmtga.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.