A phase II study of Cord blood transplantation for elderly patients with myeloid malignancies using fludarabine and intravenous busulfan in addition to cytarabine and G-CSF.

A phase II study of Cord blood transplantation for elderly patients with myeloid malignancies using fludarabine and intravenous busulfan in addition to cytarabine and G-CSF. - JSCT-FB13 CB

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010698

Enrollment

Registered

2013-05-12

Start date

2013-05-13

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: G-CSF day-8--day2 200&amp

micro

g/m2+ Cytarabine day-7-day-4 100mg/m2+Flu 180mg/m2 + ivBu 12.8mg/kg + TBI 2Gy X 2 GVHD prophylaxis: tacrolimus + oral mycophenolate mofetil (MMF)(30mg/kg/day in two divided doses, from day -1 to

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who have hematologic malignancies and who are eligible for allogeneic stem cell transplantation. 2. Age: 15-65 years old. 3. 2nd CR or subsequent CR, non CR. 1st CR as defined at least one of the following: a) Acute lymphoblastic leukemia Poor risk as defined by NCCN guidelines b) Acute Myelogenous Leukemia Greater than 1 cycle of induction therapy required to achieve remission High risk as defined by NCCN guidelines Monosomal karyotype ckit mutations with t(8;21), inv(16), t(16;16) t(7;11)(p15;p15) Preceding myelodysplastic syndrome c) Myelodysplastic syndrome high, very high as defined by WHO classification-based Prognostic Scoring System Patients who have receive ten units or more platelet transfusions per week, or two units or more RBC transfusions per month. 4.HLA matched or less than 3 antigen-mismatched CB with more than 2 X 10^7/kg nucleated cells. 5.ECOG PS:0-2 6.Those who have no severe organ dysfunction (T. Bil<2.0mg/ml, AST<=3 X upper limit of normal,ALT<=3 X upper limit of normal, Cr<2.0mg/dl, EF>50%, SpO2>95%) 7.Those who give written informed consent following sufficient explanation. 8.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 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