A phase II trial of targeted busulfan and cyclophosphamide conditioning for allogeneic hematopoietic stem cell transplantation for hematological malignancies

UMIN ID: C000000156

Registered date:13/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic Myelogenous Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome
• Date of first enrollment: 2003/10/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Check plasma busulfan concentrations over time after the first administration, and calculate the optimal dose of busulfan to achieve optimal AUC from 7th to 16th administrations.

Outcome(s)

• Primary Outcome: Overall survival at one year after transplantation
• Secondary Outcome: Disease-free survival, overall survival, pharmacokinetics of busulfan, incidence and severity of acute GVHD, incidence and severity of chronic GVHD, incidence and severity of hepatic veno-occlusive disease, mortality rate at 100 days after transplantaion, time to hematopoietic recovery, overall survival and disease-free survival in each disease group

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: (1) Uncontrollable and active infection (2) Positivity for HIV antibody and/or HBs antigen and/or HCV antibody (3) Graft manipulation such as T cell depletion (4) Impaired organ function (kidney; serum creatinine >2.0 mg/dl, Liver; aspartate aminotransferase more than 5 times high than upper limit or serum bilirubin >2.0mg/dl, heart; left ventricular ejection fraction less than 50%, lung; arterial oxygen saturation < 93% without oxygen inhalation.) (5) History of drug allergy used in the present conditioning or GVHD prophylaxis.

Related Information

• Primary Sponsor: Nagoya Blood and Marrow Transplantation Group
• Secondary Sponsor: Center for supporting hematology oncology trials
• Source(s) of Monetary Support: Nagoya Blood and Marrow Transplantation Group