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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Hyperuricemia

Thank you

Trial Information

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

Inclusion Criteria


Patients with histologically proven aggressive Non Hodgkin's Lymphoma

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

responder rate (based on normalization of uric acid levels)

Principal Investigator

ICD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

EFC4983

NCT ID:

NCT00664144

Start Date:

July 2002

Completion Date:

January 2005

Related Keywords:

  • Hyperuricemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Tumor Lysis Syndrome
  • Hyperuricemia

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