A prospective non-randomised phase II study to assess the safety and efficacy of melphalan combined with fludarabine as a reduced conditioning regimen for unrelated bone marrow transplantation for hematological malignancies (C-SHOT 0505)

UMIN ID: C000000457

Registered date:31/07/2006

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Acute myeloid leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Myelodysplastic syndrome, Chronic myelomonocytic leukemia
• Date of first enrollment: 2006/08/01
• Target sample size: 54
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Fludarabine 25mg/square meter for 5 days and melphalan 90mg/square meter for 2 days will be used as conditioning regimen. Subsequently, bone marrow graft from unrelated donor will be transplanted under immunosuppressive treatment with short-term methotrexate and tacrolimus.

Outcome(s)

• Primary Outcome: Overall survival at 100 days after transplantation
• Secondary Outcome: Time to hematopoietic recovery, grade of treatment-related toxicity, incidence and severity of acute GVHD, incidence and severity of chronic GVHD, overall survival at 1-year after transplantation, disease-free survival at 1-year after transplantation

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 55years-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)history of administration of anti-neoplastic agent within 4 weeks before transplantation (4)30% or more tumor cells of total nucleated cell count in bone marrow specimen before 28 days of registration (5)Pregnant or during breast feeding, (6)Uncontrolled another neoplastic disease, (7)Uncontrolled active psychiatric disease,(8)Uncontrolled active infection, (9)central nervous system involvement of tumor cells (10)Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen, (11) Available of a suitable related donor, (12)Patients suggested as ineligible by their attending physician

Related Information

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