NIPH Clinical Trials Search

UMIN ID: C000000457

Registered date:31/07/2006

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)

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedAcute myeloid leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Myelodysplastic syndrome, Chronic myelomonocytic leukemia
Date of first enrollment2006/08/01
Target sample size54
Countries of recruitmentJapan
Study typeInterventional
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.


Primary OutcomeOverall survival at 100 days after transplantation
Secondary OutcomeTime 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 minimum16years-old
Age maximum55years-old
GenderMale and Female
Include criteria
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


public contact
Name Tetsuya Nishida
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan Japan
Telephone 052-744-2145
Affiliation Nagoya University Graduate School of Medicine Department of Hematology and Oncology
scientific contact
Name Yoshihisa Morishita
Address 137 Omatsubara,Takaya-cho,Konan,Aichi,Japan Japan
Telephone 0587-56-4155
Affiliation JA Aichi Konan Kosei Hospital Department hematology and oncology