Status:
TERMINATED
Visilizumab for the Prevention of Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 t...
Detailed Description
The protocol plan was a two stage, controlled, phase II study to assess safety and compare the grade of acute graft-versus-host disease (GVHD) with visilizumab, or Anti-thymocyte Globulin (ATG) in com...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00720629
Start Date
December 1 2007
End Date
December 1 2013
Last Update
July 18 2014
Active Locations (1)
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1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612