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CompletedNCT00199043Updated Mar 17, 2023

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

A Phase 3 interventional study of Allopurinol and Rasburicase in Adult Acute Lymphocytic Leukemia and High-grade Lymphoma, sponsored by Goethe University. Completed at 1 site in Germany. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2023-03-17.

Sponsored by Goethe University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
15 Years and older
Sex
All
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Study summary

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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Conditions studied

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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 80 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Goethe University is the lead sponsor of 97 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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:

  • 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™
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Only 1 arm

    Drug: Allopurinol · Drug: Rasburicase

Interventions

  • DrugAllopurinol
  • DrugRasburicase
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What researchers measure

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

    after cycle 1

    Time frame: 3 weeks

Secondary outcomes

  1. response rate, incidence of tumor lysis syndrome

    after cycle 1

    Time frame: 3 weeks

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Study locations

1 site
  • University Hospital, Medical Dept. II
    Frankfurt, 60590, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00199043
Lead sponsor
Goethe University
Responsible party
Nicola Goekbuget (Study Coordinator, Goethe University) — Principal investigator
First posted
Sep 20, 2005
Start date
May 2003
Primary completion
May 2008
Completion
May 2008
Last update
Mar 17, 2023

Study contacts

Dieter Hoelzer, MD,PhD
study chair · University Hospital of Frankfurt, Medical Dept. II
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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