Status:

COMPLETED

Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma

Lead Sponsor:

Sanofi

Conditions:

Hyperuricemia

Leukemia

Eligibility:

All Genders

18-74 years

Phase:

PHASE2

Brief Summary

The primary objectives of the study are to evaluate the safety and the efficacy in patients with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days in two dosage g...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Patient suffering from:
  • acute leukemia with white blood cell (WBC) count≥ 20,000/mm3 without regard to uric acid level ; or
  • lymphoma,Stage ≥ III without regard to uric acid level; or
  • lymphomas, Stage II with bulky disease; or
  • lymphoma or leukemia, without regard to classification or morphology, with uric acid level ≥ 8.0 mg/dL, and lactate dehydrogenase (LDH) level ≥ twice the upper limit of normal (ULN).

Exclusion

    Key Trial Info

    Start Date :

    April 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2004

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT00631579

    Start Date

    April 1 2003

    End Date

    June 1 2004

    Last Update

    October 2 2009

    Active Locations (1)

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    1

    Sanofi-Aventis

    Tokyo, Japan

    Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma | DecenTrialz