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

Abstract

The FDA recommended dose of rasburicase 0.2 mg/kg/day till the resolution of TLS or up to 5 days, might be in excess and is prohibitively expensive. The quality of evidence supporting low dose rasburicase is limited. The objective is to study the plasma uric acid response rate. This is a single center, non-randomised phase II study. Duration is 10 June 2017 till 30 July 2019. Study setting is at Adult Hematolymphoid Unit, Tata Memorial Center. Participants are patients with acute leukemia and high-grade lymphomas aged >/=18 years, with ECOG PS of 0–3, with either laboratory or clinical TLS. Rasburicase was administered at fixed-dose of 1.5 mg. The subsequent doses (1.5 mg each dose) were administered only if plasma UA levels did not decline by >50% on day 2, at the physician’s discretion. We demonstrate that a low-dose rasburicase strategy leads to rapid and sustained reductions of uric acid in about 52% patients.

Keywords:

• Low-dose Rasburicase
• Tumor lysis syndrome
• Leukemia
• Lymphoma
• Dose optimisation

Acknowledgments

Authors thank Dr. M V Chandrakanth, Consultant Hemato Oncology, Medical Oncology, Narayana Superspeciality Hospital, Howrah, West Bengal, and Residents and Nurses in Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra. Mr. Melvin Joy, Statistician, CDMC, CMC Vellore, Tamil Nadu. Dr. Lakshmanan Jeyaseelan, CDMC, CMC, Vellore.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This trial did not receive funding from any source.