To study effectiveness of single dose of rasburicase in patient with blood cancer as leukemias and lymphomas who shows severe ill effect due to rapid destruction of cancer cell after receiving medications
Phase 2
- Registration Number
- CTRI/2017/10/010006
- Lead Sponsor
- Tata Memorial Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Age >18yrs
2)ECOG PS 0-3
3)Newly diagnosed acute leukemia and high-grade lymphoma.
4)Laboratory or clinical TLS according to Cairo and Bishop Criteria.
Exclusion Criteria
1) Patients with history of asthma or severe allergy
2)Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma UA response rateTimepoint: within 48 h after the start of study drug and maintaining within the normal range till day 5
- Secondary Outcome Measures
Name Time Method 1.The number of additional doses required of rasburicase <br/ ><br>Timepoint: 4 and 24 hrs after dose administration;2. The need for hemodialysis <br/ ><br>Timepoint: every monthly till 2 years;3. Mortality attributable to TLS and Adverse events due to rasburicaseTimepoint: every monthly till 2 years