pediatric solid tumor, pediatric brain tumor, malignamt lymphoma
Conditions
Sponsors
Sumitomo Dainippon Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Collected adequate dose of hematopoietic stem cells. 2) Ability to understand and the willingness to sign a written informed consent form. 3) Negative pregnancy test. 4) Taking appropriate contraceptive measures. 5) ECOG PS of 0 to 2. 6) Adequate liver function, renal function, and cardiac function.
Exclusion criteria
Exclusion criteria: 1) Receiving any treatment for primary disease. 2) Received live attenuated vaccines within 90 days. 3) Pregnant or breastfeeding. 4) Uncontrolled intercurrent illness. 5) Patients who are receiving any other investigational agents. 6) Active infection. 7) History of allergic reaction attributed to compounds of similar chemical composition. 8) HBs Ag positive, HBs Ab positive, HBc Ab positive, HCV Ab positive, or HIV Ab positive. 9) Difficult blood collection from vein. 10) Planning or received within 14 days to treat hydropericardium, pleural effusion. 11) Patients who had grapefruits or grapefruits juice, or St. John's wort within 13 days. 12) Unsuitable for the clinical trial 13) Unable to receive adequate rehydration and frequent blood transfusion. 14) Received hematopoietic stem cell transplantation within 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics Volume of distribution (Vz), Clearance, Terminal elimination halflife (t1/2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Efficacy Adverse Events, Adverse drug reactions | — |
Outcome results
None listed