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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199043

Enrollment

Registered

2005-09-20

Start date

2003-05-31

Completion date

2008-05-31

Last updated

2023-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Acute Lymphocytic Leukemia, High-grade Lymphoma

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.

Interventions

DRUGAllopurinol

DRUGRasburicase

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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	3 weeks	after cycle 1

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026