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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

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

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.

Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily

.15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.

As Needed Rasburicase

Fixed Dose Rasburicase

Saroj Vadhan-Raj, MD

Primary Objectives:

To determine the efficacy of rasburicase administered as a single dose followed by as needed dosing (investigational arm) as compared to fixed dosing for 5 days (standard treatment arm) in the treatment of patients at high risk or potential risk for tumor lysis syndrome.

Secondary Objectives:

1. To evaluate the plasma uric acid area under the curve (AUC) from baseline through 7 days
2. To evaluate the incidence of renal insufficiency and electrolyte abnormalities.
3. To determine the safety and immunogenicity of rasburicase.
4. To evaluate the cost-effectiveness of the experimental treatment (investigational arm).

The Study Drug and TLS Rasburicase is designed to help decrease or prevent the high level of uric acid that may occur during the start of chemotherapy. A high level of uric acid in the blood may lead to decreased kidney function or kidney failure.

TLS occurs when high uric acid levels are caused by breakdown of tumor cells during the start of chemotherapy. The dead tumor cells can release uric acid and cause other symptoms of kidney failure, such as releasing large amounts of potassium and phosphorus (chemicals) into the blood.

Screening Tests Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study.

Your complete medical history will be recorded. You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate), height, and weight.

Blood will be drawn (about 2 tablespoons) for routine tests. Women who are able to have children must have a negative blood (using a sample from the routine blood draw) or urine pregnancy test.

Study Groups If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. There is an equal chance of being in either group.

Group A Participants in Group A will receive rasburicase by vein, over 30 minutes, on Day 1 of Cycle 1 of chemotherapy. On Days 1-7 of Cycle 1 of chemotherapy, blood (about 2 tablespoons) will be drawn for routine tests, including a check of the level of uric acid in your blood. During Days 2-5 of Cycle 1 of chemotherapy, you will only receive rasburicase (once a day) if the levels of uric acid are high that day.

Group B Participants in Group B will receive rasburicase by vein, over 30 minutes, once a day from Days 1-5 of Cycle 1 of chemotherapy. On Days 1-7 of Cycle 1 of chemotherapy, blood (about 2 tablespoons) will be drawn for routine tests, including a check of the level of uric acid in your blood.

Both Groups Treatment with rasburicase will only be given in Cycle 1 of chemotherapy. The chemotherapy will be given at least 4 hours (up to 24 hours) after the first dose of rasburicase.

Length of Study When your blood test results show that you do not have antibodies to rasburicase, your participation in this study will be over. You will be taken off this study if the TLS gets worse or intolerable side effects occur.

This is an investigational study. Rasburicase is commercially available, but it is not FDA approved for treating TLS. It is FDA approved for pediatric patients with leukemia, lymphoma, and solid tumor cancers who are receiving anti-cancer therapy that is expected to increase the blood levels of uric acid (the result of cancer cells dying from treatment). For treating TLS in adult patients, it has been authorized for use in research only. Up to 80 evaluable patients will take part in this study. All will be enrolled at M. D. Anderson.

Rasburicase in Patients at Risk for Tumor Lysis Syndrome

Phase 2 Study of Rasburicase Administered by Two Different Schedules (Fixed Dosing vs. As Needed Dosing) in Patients at High Risk or Potential Risk for Tumor Lysis Syndrome

Plasma UA response is defined as normalization of plasma UA levels within 48 hours after the start of study drug (rasburicase) and maintaining within the normal range after the final drug infusion on day 5. Plasma samples for UA were collected at baseline before rasburicase, 4- and 24-hours post-rasburicase, and daily during treatment.

M.D. Anderson Cancer Center

Group A: Single Dose

Group B: Daily Dose

Age Continuous

United States

Region of Enrollment

Saroj Vadhan-Raj, MD / Professor

Number of Participants With Plasma Uric Acid (UA) Response

TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days

TULY

Dr. Raghunadharao D

This study is a prospective, open-label, multicentre study. Hundred eligible patients with stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a peripheral white blood cell (WBC) count of \> 25,000/µL or any leukemia or lymphoma with plasma uric acid level of at least 8 mg/dL will be treated with rasburicase 0.20 mg/kg body weight intravenously for 4 days. The primary endpoints viz., the percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and incidence of adverse events will be assessed during 11 days study period.

All eligible patients will be treated with rasburicase 0.20 mg/kg body weight intravenously for 4 days. The primary endpoints viz., the percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and incidence of adverse events will be assessed during 11 days study period.

Safety and Efficacy of TULY (Rasburicase) in Prevention and Treatment of Malignancy-associated Hyperuricemia

Efficacy and Safety of TULY in Prevention and Treatment of Malignancy-associated Hyperuricemia

Virchow Group

Respiratory Tract (Lung and Bronchial) Diseases

Asthma

Hypersensitivity

Rasburicase 0.2 mg/kg/dose by the intravenous route for up to 7 days.

Raul C. Ribeiro, MD

This is a multi-center trial for rasburicase in children at high risk of tumor lysis syndrome who have a history of asthma/atopy. The main purpose of this study is to establish the safety of this drug in patients with a history of asthma or severe allergies.

Because they were excluded from most of the clinical trials of non-recombinant urate oxidase and rasburicase, the safety of rasburicase in this population is not known, though preliminary data indicates that the drug is safe. The primary objective of this study is to estimate the proportion of grade 3 or 4 allergic reactions to rasburicase in patients with a history of asthma or severe allergy (to antigens other than rasburicase or other urate oxidases) treated with rasburicase for the prevention or treatment of malignancy or chemotherapy-induced hyperuricemia. Patients at risk of tumor lysis syndrome with a history of asthma/atopy will be treated with rasburicase according to standard practice and observed for allergic reactions.

Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients

A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma Allergies

St. Jude Children's Research Hospital

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 Director

Rasburicase 0,20mg/Kg/Day once a day 3-7 days

Jaderson Lima

The purpose of this study is to determine whether rasburicase is effective and safety in correcting hyperuricemia.

Rasburicase in Tumor Lysis Syndrome

Program of Rasburicase in the Treatment of Hyperuricemia in Children and Adolescent Patients With or at Risk of Tumor Lysis Syndrome.

Medical Affairs Study Director

Choe Seong Choon

To provide treatment opportunity to children and adolescent patients with hematologic malignancies by supplying the delayed marketed product and also to observe the efficacy and safety of rasburicase used in the treatment of hyperuricemia

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
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 in Patients at Risk for Tumor Lysis Syndrome	NCT00628628	Tumor Lysis Syn...	As Needed Rasbu... Fixed Dose Rasb...	-	M.D. Anderson Cancer Center
Safety and Efficacy of TULY (Rasburicase) in Prevention and Treatment of Malignancy-associated Hyperuricemia	NCT00921375	Hyperuricemia	TULY	1 Year - 75 Years	Virchow Group
Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients	NCT00186940	Leukemia Lymphoma Tumor Lysis Syn... Hyperuricemia	Rasburicase	-	St. Jude Children's Research Hospital
Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients	NCT00186940	Leukemia Lymphoma Tumor Lysis Syn... Hyperuricemia	Rasburicase	-	St. Jude Children's Research Hospital
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 in Tumor Lysis Syndrome	NCT00302653	Hyperuricemia	Rasburicase	- 18 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
Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome	NCT00563771	Hyperuricemia	Rasburicase	- 18 Years	Sanofi

Spots Global Cancer Trial Database for hyperuricemia