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)

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) - 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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000186

Enrollment

160

Registered

2005-09-12

Start date

1999-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute leukemia, Chronic myeloid leukemia

Interventions

Methotrexate and Tacrolimus (FK506) for GVHD prophylaxis Methotrexate and Cyclosporine A for GVHD prophylaxis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. HLA-A, B, DRB1 genotypically matched unrelated bone marrow transplantation 2. Acute leukemia (1st CR, 2nd CR) Chronic myeloid leukemia (1st CP, 2nd CP, AP) 3.Age :between 16 and 50. 4. Performance status:between 0 and 2 5. Preserved organ (liver, kidney, heart and lung) function: serum bilirubin level =60ml/min, left ventricular ejection fraction>=50%, PaO2>=70mmHg. 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. 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

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Countries

Japan

Contacts

Public ContactYoshiko Atsuta

Center for Supporting Hematology-Oncology Trials (C-SHOT) Center for Supporting Hematology-Oncology Trials (C-SHOT)

c-shot@med.nagoya-u.ac.jp052-745-3116

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026