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Tumor Lysis Syndrome

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Uric Acid

Rasburicase

Rasburicase (SR29142)

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.

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

Sanofi

ICD Study Director

Leukemia

Preleukemia

Myelodysplastic Syndromes

Allopurinol

Antimetabolites

Enzyme Inhibitors

Antioxidants

Protective Agents

Rasburicase alone given as a single agent for 5 days

Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap)

Oral allopurinol alone given as a single agent for 5 days

International Clinical Development

This is a randomized, multi-center, open-label, parallel group study with three arms:

* Rasburicase alone
* Rasburicase followed by Allopurinol
* Allopurinol alone

The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.

After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.

Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

Evaluation of Single Agent Rasburicase for 5 Days Versus Sequential Treatment With Rasburicase From Day 1 Through 3 Followed by Oral Allopurinol From Day 3 Through 5 (Overlap on Day 3) Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients With Leukemia, Lymphoma, and Solid Tumor Malignancies at Risk for Hyperuricemia and Tumor Lysis Syndrome

Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 \<7.5 mg/dl.

Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values

Time from the first dose of study drug to the time at which plasma uric acid concentrations were determined \<=7.5 mg/dl, measured -4, 4, 24, 48, 72, 96, 120, and 144 hours after infusion.

International Clinical Development, Clinical Study Director

Reported events are treatment emergent adverse events within the time frame mentioned above.

Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days

Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)

Rasburicase + Allopurinol

Allopurinol (300 mg/day) given alone as a single agent for 5 days

Total

<65 years

>=65 years

Age, Customized

Sex: Female, Male

Responder

Non-Responder

Plasma Uric Acid Responder

The analysis was performed on the modified ITT-population with an evaluation of plasma uric acid AUC.

Plasma Uric Acid

The analysis was performed on a subgroup of patients from the mITT-population with hyperuricemia immediately prior to the first dose of study drug.

Time to Uric Acid Control

Overall Study

Nutritional and Metabolic Diseases

Metabolic Diseases

Hematologic Neoplasms

rasburicase (SR29142)

Keiji OHNO

Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma uric acid concentration.

Secondary: To investigate the safety in this population and anti-SR29142 antibodies, anti-SCP antibodies, and pharmacokinetic parameters.

Rasburicase for Hyperuricemia

Open-Label, Multi-Center Study of SR29142 as Uricolytic Therapy/Prophylaxis for Hyperuricemia in Pediatric Patients With Newly Diagnosed Hematological Malignancies at High Risk for Tumor Lysis Syndrome

Study director

Hematologic Diseases

ICD CSD

This is an open-label, multi-center study with 2 arms. The primary objective is to assess the response to treatment with rasburicase in 2 populations of adult and pediatric patients with lymphoma/leukemia/solid tumor malignancies, those previously treated with a uricolytic agent, and those not previously treated with a uricolytic agent at their first relapse or refractory disease.

This is a multi-center, 2 arm, open-label study;

* Arm A: Patients previously treated with a uricolytic agent;
* Arm B: Patients not previously treated with a uricolytic agent.

Patients receive rasburicase for 5 days and begin chemotherapy 4-24 hours after the first dose of rasburicase. Patients are followed at 14 and 35 days, at 3 and 6 months and every 6 months thereafter.

Study of Rasburicase as Treatment or Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Patients With Relapsed or Refractory Lymphoma, Leukemia, or Solid Tumor Malignancy

Evaluation of Single Agent Rasburicase in Treatment/Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Adult and Pediatric Patients With Lymphoma/Leukemia/Solid Tumor Malignancies at Their First Relapse or Refractory Disease

K.K.

The primary objectives of the study are to evaluate the safety and the efficacy in patients with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days in two dosage groups.

Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to assess anti-SR29142 antibody production in patients with malignant lymphoma and acute leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the results of efficacy and safety evaluations.

Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma

Open-label, Multicenter Study of Repeated Doses of SR29142 (Rasburicase) as a Uricolytic Therapy for Hyperuricemia in Adult Patients With Leukemia or Lymphoma.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma	NCT00664144	Hyperuricemia	Rasburicase (SR...	18 Years -	Sanofi
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome	NCT00230178	Tumor Lysis Syn... Cancer Hyperuricemia	Rasburicase (SR... Allopurinol	18 Years -	Sanofi
Rasburicase for Hyperuricemia	NCT00290992	Nutritional and...	rasburicase (SR...	- 17 Years	Sanofi
Study of Rasburicase as Treatment or Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Patients With Relapsed or Refractory Lymphoma, Leukemia, or Solid Tumor Malignancy	NCT00230217	Tumors Hyperuricemia Tumor Lysis Syn...	Rasburicase (SR...	-	Sanofi
Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma	NCT00631579	Hyperuricemia Leukemia Lymphoma	Rasburicase (SR...	18 Years - 74 Years	Sanofi
Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma	NCT00664144	Hyperuricemia	Rasburicase (SR...	18 Years -	Sanofi

Spots Global Cancer Trial Database for rasburicase (sr29142)