Hematological malignancies
Conditions
Interventions
To study feasibility and effectiveness of double-unit cord blood (CB) transplantation in patients with hematological malignancies requiring hematopoietic stem cell transplantation without any availabl
Sponsors
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.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient with poor risk hematologic malignancies 2) Patient who receives double-unit CBT as first stem cell transplantation 3) Age: less than 55 years old 4) Patient without active infection at starting conditioning chemoradiatherapy 5) HIV-antibody negative patient 6) Patient who has no HLA-matched or one antigen-mismatched relatives 7) Patient who has no HLA-matched unrelated donor, or who requires urgent transplant even if he/she has HLA-matched unrelated donor 8) Patient who has no single CB unit with cell dose of more than 2.5x107/kg and 2 or more HLA antigen mismatches
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival at one year after double-unit cord blood transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShiro Yoshiba
Registry office of double-unit cord blood transplantation Research Center for regenerative medicine
Outcome results
None listed