Extended clinical study of DSP-1958
- Conditions
- pediatric solid tumor, pediatric brain tumor, malignamt lymphoma
- Registration Number
- JPRN-jRCT2080223598
- Lead Sponsor
- Dainippon Sumitomo Pharma Co., Ltd.
- Brief Summary
In conclusion, we evaluated the safety of IV thiotepa HDT prior to autologous HSCT for 41 patients with pediatric solid or brain tumors and 51 patients with malignant lymphoma. There were no new safety concerns.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 96
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.
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) HIV Ab positive.
9) Planning or received within 14 days to treat hydropericardium, pleural effusion.
10) Patients who had grapefruits or grapefruits juice, or St. John's wort within 13 days.
11) Unsuitable for the clinical trial
12) Unable to receive adequate rehydration and frequent blood transfusion.
13) Received hematopoietic transplantation within 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Safety<br>Adverse Events, Adverse drug reactions
- Secondary Outcome Measures
Name Time Method efficacy<br>other<br>Efficacy(Other) <br>100-day survival rate, engrafment