NIPH Clinical Trials Search

UMIN ID: C000000186

Registered date:12/09/2005

Phase III study comparing FK506 with Cyclosporine A for prophylaxis of acute graft-versus-host disease after HLA-A, B and DRB1 genotypically matched unrelated bone marrow transplantation (C-SHOT 0404)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedAcute leukemia, Chronic myeloid leukemia
Date of first enrollment1999/08/01
Target sample size160
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Methotrexate and Tacrolimus (FK506) for GVHD prophylaxis Methotrexate and Cyclosporine A for GVHD prophylaxis


Primary OutcomeOverall survival
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum16years-old
Age maximum50years-old
GenderMale and Female
Include criteria
Exclude criteria1. Previous transplantation. 2. Use of T cell depleted marrow. 3. Use of ATG and ALG for preparative regimen. 4. Severe dysfunction of kidney, liver and lung. 5. History of severe cardiac disease 6. History of pancreatitis and diabetes mellitus. 7. Hyperkelemia (>=5.5mEq/l) 8. Hypertension necessitating medication. 9. Active infection (including hepatitis B, hepatitis C, HIV, syphilis) 10. History of allergy or allergic response to drugs 11. Pregnant or lactating woman

Related Information


public contact
Name Yoshiko Atsuta
Address 65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi, 466-8550, Japan Japan
Telephone 052-745-3116
Affiliation Center for Supporting Hematology-Oncology Trials (C-SHOT) Center for Supporting Hematology-Oncology Trials (C-SHOT)
scientific contact
Name Yoshihisa Kodera
Address 3-35 Michishita-cho Nakamura-ku, Nagoya, Aichi 453-8511, Japan Japan
Affiliation Japanese Red Cross Nagoya First Hospital Department of Internal Medicine