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

March 15, 2023 updated by: Nicola Goekbuget, Goethe University

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60590
        • University Hospital, Medical Dept. II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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™

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Only 1 arm
Drug: Rasburicase
Drug: Allopurinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate, incidence of tumor lysis syndrome
Time Frame: 3 weeks
after cycle 1
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goethe University

Investigators

  • Study Chair: Dieter Hoelzer, MD,PhD, University Hospital of Frankfurt, Medical Dept. II

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMALL08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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