UMIN ID: UMIN000002105
Registered date:23/06/2009
Clinical trial for effectiveness and safety of WT1 peptide-pulsed allogeneic dendritic cell therapy for childhood patients with chemotherapy-resistant leukemia.
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | pediatric leukemia |
| Date of first enrollment | 2009/06/01 |
| Target sample size | 3 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Cultured dendritic cells of 1X107/dose are administered to the patient subcutaneously. This therapy is repeated every two-week, total 7 times. |
Outcome(s)
| Primary Outcome | Primary endpoint of this clinical trial is to evaluate the toxicities and adverse events of the therapy. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | 20years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.Patient with refractory GVHD. 2.Patient with active infections. 3.Patient wit thrombotic microangiopathy. 4.Patient with hepatic vein thrombosis. 5.Patient with early relapse. 6.Patient with mental, or familial, or geographycal obstacles to perform the trial. 7.Patient who is judged by the physician as not to be appropriate for the therapy. |
Related Information
| Primary Sponsor | Department of Pediatrics, Shinshu University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Shinshu University School of Medicine |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 0263-35-4600 |
| Affiliation | Shinshu University School of Medicine Department of Pediatrics |
| scientific contact | |
| Name | Shiohara Masaaki |
| Address | Asahi 3-1-1, Matsumoto Japan |
| Telephone | |
| Affiliation | Shinshu University School of Medicine Department of Pediatrics |