Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma

Study of Efficacy and Safety of Rasburicase for the Treatment/Prevention of Hyperuricemia Related to Tumor Lysis Syndrome in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma, Previously Treated or Not With Urate Oxidase Presenting With Hyperuricemia and/or Bulky Disease

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00664144

Acronym

GRAAL2

Enrollment

Registered

2008-04-22

Start date

2002-07-31

Completion date

2005-01-31

Last updated

2012-03-07

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

Conditions

Hyperuricemia

Brief summary

The primary objective was to evaluate the efficacy of rasburicase in terms of prevention and treatment of hyperuricemia related to Tumor Lysis Syndrome (TLS) in 2 populations of adult patients, previously treated or not with urate oxidase, with relapsing aggressive non-Hodgkin's lymphoma (NHL) and at risk of TLS, presenting with hyperuricemia and/or bulky disease at diagnostic of relapse. The secondary objectives were to : * evaluate the efficacy of rasburicase in terms of renal protection, * evaluate the safety of rasburicase in the two cohorts of patients, * correlate efficacy and safety results with antibodies generation/level.

Interventions

DRUGRasburicase (SR29142)

Study design

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with histologically proven aggressive Non Hodgkin's Lymphoma

Design outcomes

Primary

Measure	Time frame
responder rate (based on normalization of uric acid levels)	—

Countries

Belgium, France, Germany, Italy

Outcome results

None listed

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