Clinical phase II study of double-unit cord blood transplantation for hematological malignancies.(C-SHOT 0507)

UMIN ID: C000000359

Registered date:15/03/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hematological malignancies
• Date of first enrollment: 2006/03/01
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): To study feasibility and effectiveness of double-unit cord blood (CB) transplantation in patients with hematological malignancies requiring hematopoietic stem cell transplantation without any available single-unit CB.

Outcome(s)

• Primary Outcome: Event-free survival at one year after double-unit cord blood transplantation
• Secondary Outcome: Time of hematopoietic engraftment, treatment-related toxicity, incidence and severity of acute and chronic graft versus host disease, disease-free survival and overall survival at 1-year

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 55years-old
• Gender: Male and Female
• Exclude criteria: 1) ECOG's performance status; 2 or more 2) Ejection fraction(EF); less than 50% 3) SaO2; more than 93% in room air 4) Serum creatinine; 1.3mg/dl or greater 5) Total bilirubin; 1.6mg/dl or greater, or GOT; 2 x normal value or greater 6) Down's syndrome 7) Fanconi's anemia

Related Information

• Primary Sponsor: A Research Grant on Human Genome, Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare: Research on advancement and safety security of HSCT using umbilical cord blood.
• Source(s) of Monetary Support: A Research Grant on Human Genome, Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare: Research on advancement and safety security of HSCT using umbilical cord blood.