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OpenTrials
Completed

NCT Number: NCT00199043

Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma

In this study the efficacy and tolerability of two approaches to treat and prevent hyperuricemia is tested in patients with acute lymphoblastic leukemia or high-grade lymphoma with high risk of tumor lysis syndrome. Both arms are compared by randomisation. In one arm patients receive during pre-phase chemotherapy conventional prophylaxis with allopurinol whereas in the other arm Rasburicase is used.

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Key information

Conditions

Adult Acute Lymphocytic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases High-grade Lymphoma Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital, Medical Dept. II

Frankfurt, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients of the GMALL B-ALL/NHL-Study 2002
  • patients of the GMALL-Study 07/2003
  • patients of the GMALL-Study Elderly 1/2003 which fulfill the following criteria:
  • bulky disease (> 7.5 cm)
  • high LDH (> 2 x UNL)
  • uric acid >8 mg/dl/ >475µmol/L at diagnosis
  • leukocytes > 30 000/µl

Exclusion criteria

  • exclusion Criteria of the GMALL B-ALL/NHL Study 2002 or the GMALL-Study 07/2003 or GMALL-Elderly 1/2003 and:
  • asthma or severe, live-threatening atopic allergy in history
  • hypersensitivity against Uric acid
  • Glucose-6-Phosphate-Dehydrogenase deficiency
  • pretreatment with Rasburicase or Urikozyme™

Treatment and study plan

Allopurinol

Drug

Rasburicase

Drug

Primary outcomes

  1. renal function, uric acid, electrolytes, adverse events and mortality in pre-phase and the two following cycles of chemotherapy, time and dose compliance of chemotherapy

    Time frame: 3 weeks

    after cycle 1

Secondary outcomes

  1. response rate, incidence of tumor lysis syndrome

    Time frame: 3 weeks

    after cycle 1

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

Randomised Phase III Trial of Effectivity and Safety of Rasburicase Compared With Allopurinol for Treatment of Hyperuricemia in Patients With Acute Lymphoblastic Leukemia or High-Grade NHL With High Risk of Tumorlysis Syndrome (> 15 Yrs)

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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