A dose finding study of melphalan combined with fludarabine as a reduced conditioning regimen for unrelated bone marrow transplantation

UMIN ID: C000000325

Registered date:07/02/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Acute myeloid leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Myelodysplastic syndrome,Non-Hodgkin Lymphoma, Hodgkin Lymphoma
• Date of first enrollment: 2006/02/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Dose determination of melphalan to attain the full-donor chimerism of 28 days post-transplant by using the modified continual reassessment method

Outcome(s)

• Primary Outcome: Achievement of full donor chimerism of T-cells at 28 days post-transplant
• Secondary Outcome: (1) Disease-free survival after transplantation, (2) Overall survival after transplantation, (3) Chimerism of each cell fraction after transplantation, (4) Incidence and severity of acute GVHD, (5) Incidence and severity of chronic GVHD, (6) Grade of treatment-related toxicity, (7) Time to hematopoietic recovery

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: (1) Positive for HIV antibody and/or HBs antigen and/or HCV antibody, (2) Graft manipulation such as T cell depletion, (3) Pregnant or during breast feeding, (4) Uncontrolled psychiatric disease, (5) Uncontrolled active infection, (6) Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen, (7) Available of a suitable related donor, (8) Impaired organ function, (a) left ventricular ejection fraction smaller than 40%,(b) DLCO/FEV1.0/TLC equal to or less than 30%, (c) Total bil equal to or more than 2xULN (NCI-CTCAE Grade 3), (d) AST/ALT equal to or more than 5xULN (NCI-CTCAE Grade 3), (e) serum creatinine equal to or more than 3xULN (NCI-CTCAE Grade 3), (f) Karnofsky score equal to or less than 50

Related Information

• Primary Sponsor: Nagoya Blood and Marrow Transplantation Group
• Source(s) of Monetary Support: Nagoya Blood and Marrow Transplantation Group