pediatric leukemia
Conditions
Interventions
Cultured dendritic cells of 1X107/dose are administered to the patient subcutaneously. This therapy is repeated every two-week, total 7 times.
Sponsors
Department of Pediatrics, Shinshu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Leukemic patient who relapsed after first stem cell transplantation and received SCT from his or her parent or sibling as a donor. 2.Donor cells are engrafted to the patient. Abnormal cells are not found in bone marrow or peripheral blood. 3.Expression of WT1 in the tumor cells at relapse is more than 102 copies per microgram RNA. 4.Karnofsky score of performance status is between 80 to 100. 5.Age of the patient is less than 20. Both sex are applicable. 6.No significant complications revealed by blood and urine examinations. Blood data within 7 days before registration should meet the following criteria. a. WBC more than 1,000 per microlitter and Hb more than 7.5g per dl and platelet more than 30,000 per microlitter. Bleeding time and clotting time should be normal, regardless of transfusion dependency. b. AST and ALT should be less than 2 times of normal range of the facilities. Total bilirubin less than 2.0 mg/dl. c. Serum creatinin less than 1.0 mg/dl. d. Acute GVHD stage less than 2. 7.Physicians fully explain about the clinical study to the patient or alternative and receive informed consent from them.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint of this clinical trial is to evaluate the toxicities and adverse events of the therapy. | — |
Countries
Japan
Outcome results
None listed