CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
Rasburicase +1 moredrug
Likely dose
Rasburicase 3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01200485
NCT01200485Phase 2Completed

A Randomized Phase 2 Study to Evaluate the Efficacy of Rasburicase in Patients at Risk for TLS During Two Cycles of Chemotherapy

M.D. Anderson Cancer Center·interventional·Posted Sep 13, 2010·Updated Jan 31, 2020

In Brief

A Phase 2 clinical trial evaluating Rasburicase and Allopurinol for Leukemia and Lymphoma. Completed, enrolled 55 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if using Elitek (rasburicase) for 2 cycles can help to control or prevent TLS better than 1 cycle of rasburicase and 1 cycle of allopurinol. The safety of this treatment will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Lymphoma
CountriesUnited States
CollaboratorsSanofi

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 13, 2010
Enrollment StartApr 1, 2011
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 15.8 years ago

Interventions

Rasburicasedrug

Cycle 1: 3 mg/kg by vein on Day 1, plus as needed dosing (until day 5), during Cycle 1. Cycle 2 Arm A: 0.15 mg/kg by vein on Day 1 of Cycle 2, plus as needed dosing (until day 5), during Cycle 2.

Allopurinoldrug

Arm B: 300 mg/day by vein, as standard of care, over 30 minutes each day on days 1-5 of cycle 2 in 21 day cycle.