Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma
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)
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2003
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedMarch 17, 2023
March 1, 2023
5 years
September 12, 2005
March 15, 2023
Conditions
Outcome Measures
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
3 weeks
Secondary Outcomes (1)
response rate, incidence of tumor lysis syndrome
3 weeks
Study Arms (1)
Only 1 arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- asthma or severe, live-threatening atopic allergy in history
- hypersensitivity against Uric acid
- Glucose-6-Phosphate-Dehydrogenase deficiency
- pretreatment with Rasburicase or Urikozyme™
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital, Medical Dept. II
Frankfurt, 60590, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dieter Hoelzer, MD,PhD
University Hospital of Frankfurt, Medical Dept. II
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Coordinator
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
May 1, 2003
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
March 17, 2023
Record last verified: 2023-03