A phase II study of HLA matched related bone marrow or peripheral blood stem cell transplantation for elderly patients with hematologic malignancies using fludarabine and intravenous busulfan.

A phase II study of HLA matched related bone marrow or peripheral blood stem cell transplantation for elderly patients with hematologic malignancies using fludarabine and intravenous busulfan. - JSCT-FB10 PB/BM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004213

Enrollment

Registered

2010-09-15

Start date

2010-09-10

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

AML,MDS

Interventions

Conditioning regimen: Flu 180mg/m2 + ivBu 12.8mg/kg +- TBI 2Gy GVHD prophylaxis: HLA matched related BM or PBSC donor cyclosporine A(CsA) + short-term methotrexate(MTX)(day 1: 10mg/m2, day

s decision.)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed as AML or MDS who meet the following conditions, (a)Patients with AML(except M3)who are in advanced stage beyond first complete remission, are in high risk disease category according to SWOG/ECOG criteria, received more than one course of chemotherapy to achieve complete remission, AML/MLD in first remission, or AML with prior history of myelodysplastic syndrome (B)Patients with MDS who are in poor prognosis group with high or very high score according to WHO classification-based prognostic scoring system, or required platelet transfusions of at least 10 units/week or red cell transfusions of at least 2 units/month. 2.Age:55-70 3.Those who have available donors(HLA-identical or 1 antigen-mismatched related BM/PBSC, HLA-matched or 1 DR antigen-mismatched unrelated BM 5.Those who have no severe organ dysfunction (T. Bil<2.0mg/dL, AST<=3 X upper limit of normal,ALT<=3 X upper limit of normal, Cr<2.0mg/dl, EF>50%, SpO2>95%) 6.Those who give written informed consent following sufficient explanation. 7.Those who are evaluated to be able to survive more than 3 months.

Exclusion criteria

Exclusion criteria: 1.Those who are positive for anti-HIV antibody 2.Those who have history of gemtuzumab ozogamicin (MylotargTM) use within 4 months 3.Those who have coinciding active malignancies 4.Those who have uncontrolled psychiatric disorder 5.Those who have active infection 6.Those who have prior hematopoietic stem cell transplantation 7.Those who have history of chemotherapy within 30 days before transplant (except hydroxycarbamide or cytarabine therapy for blast control) 8.Those who have hypersensitivity to drugs included in this protocol therapy 9.Those who are considered as inappropriate to register by attending physicians.

Design outcomes

Primary

Measure	Time frame
Event-free survival at 1 year after transplantation	—

Countries

Japan

Outcome results

None listed

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