CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 280 enrolled
Drug / intervention
Rasburicase (SR29142) +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓High risk for TLS: hyperuricemia (uric acid >7.5 mg/dL), very aggressive lymphoma/leukemia per REAL classification, AML, CML in blast crisis, or high-grade MDS with >10% bone marrow blasts receiving aggressive treatment
  • ✓Potential risk for TLS: aggressive lymphoma/leukemia per REAL classification plus at least one of: LDH ≥2x ULN, Stage III-IV disease, or Stage I-II with at least one lymph node/tumor >5 cm
  • ✓Age ≥18 years
  • ✓Life expectancy >3 months
Key exclusion· 0

None specified.

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

Search/NCT00230178
NCT00230178Phase 3Completed
CompareCT.gov

Evaluation of Single Agent Rasburicase for 5 Days Versus Sequential Treatment With Rasburicase From Day 1 Through 3 Followed by Oral Allopurinol From Day 3 Through 5 (Overlap on Day 3) Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients With Leukemia, Lymphoma, and Solid Tumor Malignancies at Risk for Hyperuricemia and Tumor Lysis Syndrome

Sanofi·interventional·Posted Sep 30, 2005·Updated Jan 12, 2010

In Brief

A Phase 3 clinical trial evaluating Rasburicase (SR29142) and Allopurinol for Tumor Lysis Syndrome and 2 related conditions. Completed, enrolled 280 participants across 15 sites.

Detailed Summary

This is a randomized, multi-center, open-label, parallel group study with three arms: * Rasburicase alone * Rasburicase followed by Allopurinol * Allopurinol alone The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTumor Lysis Syndrome, Cancer, Hyperuricemia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 30, 2005
Enrollment StartApr 1, 2004
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 20.8 years ago

Interventions

Rasburicase (SR29142)drug

30-min IV infusion

Allopurinoldrug

Oral administration