Visilizumab for the Prevention of Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to test whether a new drug named visilizumab would decrease the severity of graft-versus-host disease in patients treated with a mismatched donor. Investigators planned to use visilizumab in combination with tacrolimus and methotrexate as the "study treatment".

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Antilymphocyte Serum; Methotrexate; Tacrolimus; Thymoglobulin; Visilizumab

Criteria

Inclusion Criteria:

• One of the following diagnoses with histological confirmation by the Pathology Department at H. Lee Moffitt Cancer Center:

• Acute Lymphocytic Leukemia (ALL) in complete remission 1 (CR1) with t(9:22) or t(4:11), or any ALL beyond CR1

• Acute Myelogenous Leukemia (AML) with high risk cytogenetics in CR1 as defined by Bloomfield any AML beyond CR1

• Myelodysplastic Syndrome (MDS) with International Prognostic Scoring System (IPSS) score > 1

• Chronic myelomonocytic leukemia (CMML)

• Chronic Myelogenous Leukemia (CML) with Imatinib-refractory chronic phase, or beyond chronic phase by morphology or cytogenetics

• Myelofibrosis

• Severe aplastic anemia

• Chemosensitive Non-Hodgkin's lymphoma and Hodgkin's disease that are not candidate to autologous transplant due to prior autologous transplantation

• Multiple Myeloma patient not candidate for autologous stem cell transplantation

• Karnofsky performance status ≥ 70% (adult)

• Normal organ and marrow function as defined below:

• Hepatic: Total bilirubin must be less than or equal to 2mg/dL (Gilbert and other syndromes with increased indirect bilirubin are allowed); serum transaminases must be less than two times the upper limit of normal

• Pulmonary: diffusing capacity of lung for carbon monoxide (DLCO) (corrected for Hgb), forced expiratory volume-one second (FEV1), forced vital capacity (FVC) must be greater than 50% predicted

• Cardiac: Left ventricular ejection fraction at rest must be greater than 50%

• Renal: Creatinine clearance (measured or calculated) must be equal or greater than 50 ml/min/1.73m^2

Exclusion Criteria:

• Anti thymocyte globulin (ATG) or anti T cell therapy in prior 45 days

• Splenectomized patients;

• A positive pregnancy test administered to all females of childbearing potential prior to allogeneic stem cell transplant

• Inability to comply with follow up as determined by the patient's physician

• HIV-I/II infection prior to hematopoietic stem cell (HSC) transplantation, confirmed by nucleic acid test (NAT)

• Uncontrolled bacterial or fungal infection

• History of documented invasive aspergillosis or cytomegalovirus (CMV) pneumonia

• Presence of any of the following comorbid conditions:

• History of myocardial infarction

• Congestive heart failure (even if symptomatically controlled)

• Peripheral vascular disease (including intermittent claudication or history of bypass for arterial insufficiency)

• Untreated thoracic or abdominal aneurysm (6cm or more)

• History of any cerebrovascular accident including transient ischemic attacks

• Dementia

• History of peptic ulcer disease requiring treatment

• Connective tissue/rheumatologic disorders

• Diabetes unless being managed with dietary changes only

• Hemiplegia/paraplegia

• History of solid tumor excluding skin or cervical carcinoma after curative resection