UMIN ID: UMIN000000515
Registered date:10/11/2006
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
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Acute leukemia |
| Date of first enrollment | 2006/11/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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 transplantation |
Outcome(s)
| Primary Outcome | Hematopoietic engraftment at 100 days after cord blood transplantation |
|---|---|
| Secondary Outcome | 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 |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | 16years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Research Grant on Human Genome, Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Research Grant on Human Genome, Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shiro Yoshiba |
| Address | Boseidai, Isehara-city, Kanagawa Japan |
| Telephone | 0463-93-1121 |
| Affiliation | Registry office of cord blood transplantation in children 2) Research Center for regenerative medicine, Tokai University, School of Medicine |
| scientific contact | |
| Name | 1) Shun-ichi Kato, 2) Keiichi Isoyama |
| Address | 1) Boseidai, Isehara-city, Kanagawa,2)1-30 Fujigaoka Aoba-ku Yokohama Japan |
| Telephone | 0463-93-1121 |
| Affiliation | 1) Tokai University, School of Medicine 2) Showa University Fujigaoka Hospital 1) Research Center for regenerative medicine ,2) Department of Pediatrics |