Study for the establishment of conditioning regimen in cord blood transplantation for children: To evaluate feasibility and effectiveness of cord blood transplantation using the conditioning regimen including Fludarabine phosphate for children with acute leukemia

Study for the establishment of conditioning regimen in cord blood transplantation for children: To evaluate feasibility and effectiveness of cord blood transplantation using the conditioning regimen including Fludarabine phosphate for children with acute leukemia - Clinical study to evaluate feasibility and effeteness of conditioning regimen using Fludarabine phosphate (C-SHOT-0602)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000515

Enrollment

Registered

2006-11-10

Start date

2006-11-01

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

Interventions

To study feasibility and effectiveness of cord blood transplantation using the conditioning regimen including Frudarabine phosphate in children with acute leukemia requiring hematopoietic stem cell

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Children with acute leukemia requiring unrelated cord blood transplantation because of the lack of a suitable donor. 2)Patient who receives CBT as the first haematopoietic stem cell transplantation 3)Age:equal or older than 6 month old, younger than 16 years old 4)Children who has cord blood unit with a cell dose of equal or more than 2x107/kg and HLA 2=>antigens mismatches 5)Children without hypersensitivity to drugs given for conditioning and GVHD prophylaxis. 6)The written informed consent is available.

Exclusion criteria

Exclusion criteria: 1)Intracranial hemorrhage 2)ECOG's performance status;2 or more 3)Children with cardiovascular diseases requiring treatment 4)Children with respiratory dysfunction requiring oxygen 5)Serum creatinine>3 x age adjusted normal value 6)Total bilirubin>2 x age adjusted normal value 7)Down's syndrome or Fragile chromosome syndrome 8)Children with uncontrollable infection 9)History of organ transplantation 10)Children registered to other clinical study for hematopoietic cell transplantation 11)Physician's decision that it is not appropriate to register the patient to this study for other reasons.

Design outcomes

Primary

Measure	Time frame
Hematopoietic engraftment at 100 days after cord blood transplantation	—

Secondary

Measure	Time frame
Over all survival at 1 year after transplant, Event free survival at 1 year after transplant, Preconditioning-related toxicity, Incidence and severity of acute and chronic graft versus host disease, Time of onset of GVHD, Time interval between transplant and hematological recovery Chimerism analysis	—

Countries

Japan

Contacts

Public ContactShiro Yoshiba

Registry office of cord blood transplantation in children 2) Research Center for regenerative medicine, Tokai University, School of Medicine

0463-93-1121

Outcome results

None listed

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