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

Sponsor

Johann Wolfgang Goethe University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00199043

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adult Acute Lymphocytic Leukemia High-Grade Lymphoma	Drug: Allopurinol Drug: Rasburicase	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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)

Study Start Date :

May 1, 2003

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

May 1, 2008

Outcome Measures

Primary Outcome Measures

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 []

Secondary Outcome Measures

response rate, incidence of tumor lysis syndrome []

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts 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