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

A phase II non-randomized study to evaluate the efficacy of single dose rasburicase (1.5mg) in adult acute leukemia and high grade lymphomas with established tumor lysis syndrome

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/10/010006

Enrollment

Registered

2017-10-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C950- Acute leukemia of unspecified celltype Health Condition 2: C950- Acute leukemia of unspecified celltype Health Condition 3: C910- Acute lymphoblastic leukemia [ALL] Health Condition 4: C920- Acute myeloblastic leukemia Health Condition 5: C92A- Acute myeloid leukemia with multilineage dysplasia Health Condition 6: C929- Myeloid leukemia, unspecified Health Condition 7: null- Newly diagnosed acute leukemia and high grade lymphoma Health Condition 8: C859- Non-Hodgkin lym

Interventions

Intervention1: Rasburicase: Single dose of 1.5 mg of active substance to be reconstituted in 1 ml of reconstitution solution administered intravenously over 30 minutes Control Intervention1: Not Any:

Eligibility

Inclusion criteria

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

Exclusion criteria: 1) Patients with history of asthma or severe allergy 2)Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Design outcomes

Primary

Measure	Time frame
Plasma UA response rateTimepoint: within 48 h after the start of study drug and maintaining within the normal range till day 5	—

Secondary

Measure	Time frame
1.The number of additional doses required of rasburicase Timepoint: 4 and 24 hrs after dose administration;2. The need for hemodialysis Timepoint: every monthly till 2 years;3. Mortality attributable to TLS and Adverse events due to rasburicaseTimepoint: every monthly till 2 years	—

Countries

India

Contacts

Public ContactDr Hasmukh Jain

Tata Memorial Center, Parel, Mumbai

dr.hkjain@gmail.com2224146937

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026