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Safety and efficacy of conditioning regimen with once-daily intravenous busulfan and fludarabine or cyclophosphamide for allogeneic hematopoietic stem cell transplantation in acute myelogenous leukemia or myelodysplastic syndrome

Safety and efficacy of conditioning regimen with once-daily intravenous busulfan and fludarabine or cyclophosphamide for allogeneic hematopoietic stem cell transplantation in acute myelogenous leukemia or myelodysplastic syndrome - Efficacy of conditioning regimen with FLU/BU(QD) or BU(QD)/CY for HSCT in AML/MDS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015647
Enrollment
30
Registered
2014-11-10
Start date
2014-03-04
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 myelogenous leukemia, myelodysplastic syndrome

Interventions

once-daily intravenous busulfan

Sponsors

Second Department of Internal Medicine, Shinshu University of School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: PS (ECOG) is 0 to 2 no sever organ dysfunction (T.Bil<2.0 mg/dL, AST/ALT =>3XUNL, CCr<2.0mg/dl, EF>50%, SpO2>95%) patients will survive more than three months AML(without FAB M3) or MDS patients transplant from following donors: HLA (A, B, DR) 6/6 allele matched related or unrelated donor HLA (A, B, DR) 5/6 allele matched related or unrelated donor less than 2 HLA (A, B, DR) antigens mismatched cord blood with =>2X10E7/kg nuclear cells patients obtained informed consent

Exclusion criteria

Exclusion criteria: patients with antibody of HIV patients has other malignancies patients has uncontrollable psychiatric disorders patients has active infections patients has history of hematopoietic stem cell transplantation patients has allergy of the drugs that use in protocol pregnant woman

Design outcomes

Primary

MeasureTime frame
event-free survival at day 100 from transplantation

Countries

Japan

Contacts

Public ContactToshiro Ito

Shinshu University of School of Medicine Second Department of Internal Medicine

itot@shinshu-u.ac.jp0263-37-2634

Outcome results

None listed

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