Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma (GRAAL2)

Sanofi

Status and phase: Terminated; Phase 2

Conditions: Hyperuricemia

Treatments: Drug: Rasburicase (SR29142)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00664144

EFC4983

L_8433

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients with histologically proven aggressive Non Hodgkin's Lymphoma