Status:
COMPLETED
A Study of Tacrolimus/Methotrexate and Tocilizumab to Prevent Acute Graft-Versus-Host Disease (AGVD) After Allogeneic Hematopoietic Stem Cell Transplant
Lead Sponsor:
William R. Drobyski, MD
Conditions:
Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II open label trial designed to evaluate the efficacy of Tac/MTX/Toc in preventing graft versus host disease (GVHD). Outcomes of patients on this clinical trial will be compared to tho...
Detailed Description
This is a Phase II open label trial designed to evaluate the efficacy of Tacrolimus (Tac), Methotrexate (MTX) and Tocilizumab (Toc) (combined Tac/MTX/Toc) in preventing graft versus host disease (GVHD...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Patients with acute leukemia, chronic myelogenous leukemia, myeloproliferative disease and myelodysplasia with less than 5% of blasts in the bone marrow
- Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, Non-Hodgkin Lymphoma or Hodgkin Disease with chemosensitive disease at time of transplant
- Planned conditioning regimens including combination of busulfan and fludarabine or busulfan and cyclophosphamide
- Transplantation with T-cell-replete grafts
- Bone marrow or mobilized peripheral blood cell grafts
- Patients must have either a sibling donor (6/6 match at human leukocyte antigens (HLA-A, -B and -DRB1) or a unrelated donor (8/8 match at HLA-A, -B, -C and -DRB1)
- Cardiac function: Ejection fraction at rest \>45% for myeloablative conditioning or \>40% for reduced intensity conditioning
- Estimated creatinine clearance greater than 50 mL/minute (using the Cockcroft-Gault formula and actual body weight)
- Pulmonary function: Diffusing Capacity of Lung for Carbon Monoxide (DLCO) ≥40% (adjusted for hemoglobin) and FEV1≥50%
- Liver function: total bilirubin \< 1.5 x the upper limit of normal and alanine aminotransferase (ALT) / aspartate aminotransferase (AST) \< 2.5x the upper normal limit
- Signed informed consent
Exclusion
- Prior allogeneic hematopoietic cell transplant (HCT)
- Karnofsky Performance Score \<70%
- Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression of infectious disease or no clinical improvement) at time of enrollment
- Prior intolerance or allergy to Tocilizumab
- Use of rituximab, alemtuzumab, anti-thymocyte globulin (ATG) or other monoclonal antibody at time of conditioning regimen
- History of diverticulitis, Crohn's disease or ulcerative colitis
- History of demyelinating disorder
- Pregnant and lactating women
- Patients with a history of rheumatologic disorders who have previously received Tocilizumab
- Eligibility for the Control Arm
- Patients in the control arm will be identified from patients reported to the CIBMTR from U.S centers. Control patients will be required to satisfy similar eligibility requirements as patients being enrolled in the clinical trial. Patients will need to fulfill the same inclusion criteria for the clinical trial according to Section 2.4.1, plus the following:
- Receive Tac/MTX as the sole GVHD prophylaxis approach
- Receive the same regimens as specified in Table 2.5
- Year of transplant from 2010 to 2013
- Exclusion criteria for the controls:
- 1\. Karnofsky Performance Score \< 70%
- Data for all eligible patients will be used to constitute the control database for this study
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02206035
Start Date
December 1 2014
End Date
September 1 2018
Last Update
March 9 2023
Active Locations (1)
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1
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226