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Not Recruiting
Trial ID: NCT00568633
A California Cooperative Clinical Study Comparing Allogeneic Hematopoietic Cell Transplantation Using Nonmyeloablative Host Conditioning With Total Lymphoid Irradiation and Anti-thymocyte Globulin Versus Best Standard of Care in Acute Myeloid Leukemia (AML) in First Complete Remission
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Professor of Medicine (Hematology)
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)
INCLUSION CRITERIA
- ≥ 50 years of age and ≤ 75 years of age.
- De novo acute myelogenous leukemia (AML), based on FAB and WHO criteria.
- Intermediate or unfavorable cytogenetic abnormalities based on Southwest Oncology
Group (SWOG) Cytogenetic Criteria.
- First morphologic complete remission (CR), or CRp (a complete remission but with low
platelets) following 1 or 2 courses of induction therapy, documented no more than 8
weeks prior to the date of enrollment and confirmed at time of enrollment.
- Karnofsky Performance Score ≥ 60.
- Suitable for non-myeloablative transplantation or best treatment.
- Able to understand and willing to sign a written informed consent document.
EXCLUSION CRITERIA
- AML with favorable cytogenetic features based on SWOG Cytogenetic Criteria
- AML, either treatment-related or MDS-related
- Active CNS disease as identified by positive CSF cytospin at time of enrollment.
- Prior or concurrent malignancies except localized non-melanoma skin malignancies or
treated cervical carcinoma in situ. (EXCEPTION: Cancer treated with curative intent >
5 years previously is allowed. EXCEPTION: Low grade lymphoma is allowed as long as
active treatment is not required for control of disease)
- Planned for allogeneic transplant using a full-dose conditioning
- Life expectancy < 1 year due to diseases other than malignancy
- Pregnant or breastfeeding.
- HIV-seropositive.
- Uncontrolled infection (presumed or documented) with progression after appropriate
therapy for greater than one month.
- Symptomatic coronary artery disease or uncontrolled congestive heart failure. Left
ventricular ejection fraction (LVEF) is not required to be measured, however if
measured, exclusion if ejection fraction is < 30%.
- Requiring supplementary continuous oxygen. Diffusing capacity of the lungs for carbon
monoxide (DLCO) is not required to be measured, however if it is measured, exclusion
if DLCO < 35%.
- Fulminant liver failure
- Cirrhosis with evidence of portal hypertension or bridging fibrosis
- Alcoholic hepatitis
- Esophageal varices
- A history of bleeding esophageal varices
- Hepatic encephalopathy
- Uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the
prothrombin time
- Ascites related to portal hypertension
- Chronic viral hepatitis with total serum bilirubin > 3 mg/dL
- Symptomatic biliary disease
procedure: Allogeneic HSCT
drug: Anti-thymocyte globulin (ATG)
drug: Cyclosporine (CSP)
drug: Mycophenolate mofetil (MMF)
radiation: Total lymphoid irradiation (TLI)
drug: Methylprednisolone sodium succinate
drug: Best standard care
Not Recruiting
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