NIPH Clinical Trials Search

UMIN ID: UMIN000000868

Registered date:29/10/2007

Phase II study of cord blood transplantation using myeloablative conditioning in adult patiants (C-SHOT 0603)

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedAcute leukemia, Chronic myelogenous leukemia, Myelodysplastic syndrome
Date of first enrollment2007/10/01
Target sample size28
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Conditioning regimen for cord blood transplant was twelve gray (Gy) total body irradiation (TBI), Cyclophosphamide (CPA) and high dose Ara-C with G-CSF for myeloid hematological malignant diseases, and 12 Gy TBI, CPA and high dose Ara-C for lymphoid hematological malignant diseases. Cyclosporine (10 hours continuous) and short-term Methotrexate (MTX; 15 mg/m2 Day 1, 10 mg/m2 Days 3, 6) are used for GVHD prophylaxis. Eligible single cord blood unit is infused without processing on the day of transplant (Day 0) after rapid thawing in 37 degree Celsius thermostat bath.


Primary OutcomeEvent-free survival at one year after cord blood transplantation
Secondary Outcome1.Incidence and time of engraftment 2.Incidence and severity of acute GVHD 3.Incidence and severity of chronic GVHD 4.Disease-free survival and overall survival 5.Causes and incidence of sever toxicity 6.Incidence of relapse 7.Incidence of treatment-related toxicity (TRM) 8.Analysis of incidences of TRM between institutions

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum55years-old
GenderMale and Female
Include criteria
Exclude criteria1.Active disease in central nerve system. 2.Uncontrollable diabetes 3.Uncontrollable hypertension 4.Active infection 5.Positive for TPHA or HBs antigen 6.Positive for HIV antibody 7.Malignancies addition to primary hematological malignant disease 8.Pregnant or during breast feeding 9.History of stem cell transplantation including autologous transplantation 10.Uncontrollable psycho-neurological symptoms 11.Physician's decision that it is not appropriate to register the patient to this study for other reasons

Related Information


public contact
Name Satoshi Takahashi
Address 4-6-1 Shiroganedai,Minato-ku,Toukyou Japan
Telephone 03-3443-8111
Affiliation The University of Tokyo Institute of Medical Science attachment hospital Internal Medicine
scientific contact
Name Shun-ichi Kato
Address 143 Shimokasuya,Isehara-city, Kanagawa Japan
Telephone 0463-93-1121
Affiliation Tokai University, School of Medicine Research Center for regenerative