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Prophylaxis of acute GVHD after bone marrow transplantation from unrelated donors with C3 monitoring of cyclosporine: a multicenter prospective study.

Prophylaxis of acute GVHD after bone marrow transplantation from unrelated donors with C3 monitoring of cyclosporine: a multicenter prospective study. - Prophylaxis of acute GVHD with C3 monitoring of cyclosporine.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002817
Enrollment
70
Registered
2009-12-01
Start date
2009-12-01
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

Hematological malignancy

Interventions

Dose adjustment of cyclosporine by monitoring of its blood levels

Sponsors

Cellular Transplantation Biology, Kanazawa University Graduate School of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with hematological malignancies who undergo bone marrow transplantation from unrelated donors. 2) Donors need to be HLA-A, B, C, DRB1 genotypically matched, HLA-A, B, C genotypically matched and DRB1 single allele mismatched or HLA-A, B, DRB1 genotypically matched and HLA-C single allele mismatched and KIR matched. 3) Patients who can give written informed consent to the enrollment into this trial.

Exclusion criteria

Exclusion criteria: 1) Non-myeloablative allogeneic transplantation 2) Past transplantation history 3) T-cell depleted transplantation 4) Use of ATG or ALG as preparative regimens 5) Serum creatinine level >= 2.0 mg/dL or >= 1.5 times the upper limit of the normal range, Ccr < 50 mL/min 6) Serum total bilirubin level >= 2.0 mg/dL, serum AST/ALT level >= 2 times the upper limit of the normal range 7) Uncontrolled hypertension 8) Uncontrolled diabetes mellitus on insulin therapy 9) Uncontrolled active infections 10) History of epilepsy 11) Other severe complications 12) Pregnant female 13) Allergic to cyclosporine 14) Any patients who are judged unsuitable for the enrollment by the attending physician

Design outcomes

Primary

MeasureTime frame
Incidence of grade II-IV and grade III-IV acute GVHD within 100 days after bone marrow transplantation.

Countries

Japan

Contacts

Public ContactHirohito Yamazaki

Kanazawa University Graduate School of Medical Science Cellular Transplantation Biology

hyamazaki@med3.m.kanazawa-u.ac.jp076-265-2275

Outcome results

None listed

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