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Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation


N/A
18 Years
70 Years
Open (Enrolling)
Both
Acute GVH Disease

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Trial Information

Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation


This is a comparative study to assess the biologic and clinical activity of the agent
ustekinumab when given in concert with our established regimen of SIR/TAC. Patients will be
randomly assigned between the standard regimen of tacrolimus/sirolimus (TAC/SIR + placebo)
vs. the investigational regimen of tacrolimus/sirolimus/ustekinumab (TAC/SIR/U) in a 1:1
scheme


Inclusion Criteria:



- Hematologic disorder requiring allogeneic hematopoietic cell transplantation

- Adequate vital organ function:

- LVEF >/= 45% by MUGA scan

- FEV1, FVC, and DLCO >/= 50% of predicted values on pulmonary function tests

- Transaminases (AST, ALT) < 3 times upper limit of normal values

- Creatinine clearance >/= 50 cc/min.

- Performance status: Karnofsky Performance Status Score >/= 60%.

Exclusion Criteria:

- Active infection not controlled with appropriate antimicrobial therapy

- HIV, hepatitis B, or hepatitis C infection

- Sorror's co-morbidity factors with total score > 3

- Important modification to co-morbidity index calculation: DLCO will not be included
in assessment of pulmonary risk, excepting those with DLCO < 50%, who will merit a
score of 3 and thereby be excluded from the trial.

- Anti-thymocyte globulin (ATG) as part of the conditioning regimen

- Cyclophosphamide as part of the conditioning regimens

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Treg/total CD4+ ratio

Outcome Description:

Treg/total CD4+ ratio at day 30 following HCT

Outcome Time Frame:

30 days post transplant

Safety Issue:

No

Principal Investigator

Joseph Pidala, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC - 16743

NCT ID:

NCT01713400

Start Date:

February 2013

Completion Date:

November 2014

Related Keywords:

  • Acute GVH Disease
  • Acute Graft vs Host Disease
  • aGVHD
  • GVHD
  • Graft vs Host Disease

Name

Location
H Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612