Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Pediatric Patients With Non-Hodgkin's Lymphoma and Acute Leukemia (RAISE)
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
RASBURICASE SR29142
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma
Eligibility Criteria
Inclusion criteria :
- Patient or parent/legal guardian is willing and able to provide signed informed consent, and if required, the patient is willing to provide assent.
- Children or adolescent aged 2 to 18 years old (inclusive) at time of signing of informed consent.
- At screening, the patient is expected to have a minimum life expectancy of 45 days and has a performance status (PS) no greater than 3 on the Eastern Cooperative Oncology Group (ECOG) scale, or a PS no less than 30 on the Lansky score as per the Investigator's preference (see Appendix D for ECOG and Lansky scale).
- Newly diagnosed NHL or AL who is at the initiation of or during the first cycle of chemotherapy,baseline blood uric acid greater than 8 mg/dL (473 mol/L) at screening.
- If newly diagnosed NHL patient with blood uric acid no greater than 8 mg/dL at screening, the patient must be diagnosed with Stage III or IV non-Hodgkin's lymphoma with high tumor burden which will be high risk of TLS defined, with one or more of following below: A. Burkitt lymphoma/leukemia or -lymphoblastic lymphoma, and/or B. Has at least one of lymph node or tumor, the diameter >5 cm, and/or C. Lactate dehydrogenase (LDH) no less than 2 times the upper limit of normal (ULN).
- If newly diagnosed AL patient is with blood uric acid no greater than 8 mg/dL at the screening but with a high risk of TLS defined with one of the following below criteria: A. White blood cell (WBC) no less than 100.0 10-9/L, or B. WBC < 100.0 10-9/L with LDH no less than 2 ULN.
- The patient will receive the chemotherapy, and will be confined in hospital for at least 14 days after first dose of rasburicase.
Exclusion criteria:
- Acute promyelocytic leukemia
- Patient who has been treated or planned to receive allopurinol within 72 hours of rasburicase administration.
- Patients with abnormal liver or renal function: alanine aminotransferase (ALT) >5 ULN, total bilirubin >3 ULN, serum creatinine >3 ULN.
- Documented history of hereditary allergy or asthma.
- Patients with known deficiency of glucose-6-phosphate dehydrogenase (G6PD), or a history of hemolytic disease or methemoglobinemia.
- Patients with severe infection or active bleeding.
- Previous therapy with urate oxidase.
- Hypersensitive reaction against rasburicase or any of the other ingredients of the study drug.
- Patient is not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures.
- Pregnant or breastfeeding woman.
- Woman of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy (see contraceptive guidance in Appendix A).
- Male participant with a female partner of childbearing potential not protected by highly-effective method(s) of birth control
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- investigational site CHINA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rasburicase
Arm Description
rasburicase 0.20 mg/kg/day by intravenous (IV) over 30 minutes for 1 to 5 days according to the level of plasma uric acid or Investigator's clinical judgement
Outcomes
Primary Outcome Measures
Incidence of AEs and SAEs
Incidence of AE or SAE will be summarized as the number and percentage of subjects who experienced any AE or SAE during the treatment period.
Secondary Outcome Measures
Number of responders after completion of rasburicase treatment under chemotherapy
Response will be defined as achievement of normal uric acid levels (≤ 8.0 mg/dL) in those patients whose uric acid levels are >8.0 mg/dL.
Proportion of patients who can maintain the normal uric acid levels throughout the study
In those patients whose baseline plasma uric acid levels are ≤ 8 mg/dL but with a high risk of TLS.
Percentage of the maximum decreasing degree of plasma uric acid level from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04349306
Brief Title
Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Pediatric Patients With Non-Hodgkin's Lymphoma and Acute Leukemia
Acronym
RAISE
Official Title
An Open-label, Single-arm, Multi-center Study to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec) in the Prevention and Treatment of Hyperuricemia in Pediatric Patients With Non-Hodgkin¿s Lymphoma and Acute Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 14, 2020 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
March 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary Objective:
To evaluate safety of rasburicase in pediatric patients with NHL and AL
Secondary Objective:
To assess efficacy of rasburicase for prevention and treatment of hyperuricemia
Detailed Description
Study duration per participants is approximatively 14 days including a 5-day treatment period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rasburicase
Arm Type
Experimental
Arm Description
rasburicase 0.20 mg/kg/day by intravenous (IV) over 30 minutes for 1 to 5 days according to the level of plasma uric acid or Investigator's clinical judgement
Intervention Type
Drug
Intervention Name(s)
RASBURICASE SR29142
Intervention Description
Pharmaceutical form:solution for infusion Route of administration: intravenous
Primary Outcome Measure Information:
Title
Incidence of AEs and SAEs
Description
Incidence of AE or SAE will be summarized as the number and percentage of subjects who experienced any AE or SAE during the treatment period.
Time Frame
Day 1 to Day 7
Secondary Outcome Measure Information:
Title
Number of responders after completion of rasburicase treatment under chemotherapy
Description
Response will be defined as achievement of normal uric acid levels (≤ 8.0 mg/dL) in those patients whose uric acid levels are >8.0 mg/dL.
Time Frame
Day 1 to Day 7
Title
Proportion of patients who can maintain the normal uric acid levels throughout the study
Description
In those patients whose baseline plasma uric acid levels are ≤ 8 mg/dL but with a high risk of TLS.
Time Frame
Day 1 to Day 7
Title
Percentage of the maximum decreasing degree of plasma uric acid level from baseline
Time Frame
Day 1 to Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
Patient or parent/legal guardian is willing and able to provide signed informed consent, and if required, the patient is willing to provide assent.
Children or adolescent aged 2 to 18 years old (inclusive) at time of signing of informed consent.
At screening, the patient is expected to have a minimum life expectancy of 45 days and has a performance status (PS) no greater than 3 on the Eastern Cooperative Oncology Group (ECOG) scale, or a PS no less than 30 on the Lansky score as per the Investigator's preference (see Appendix D for ECOG and Lansky scale).
Newly diagnosed NHL or AL who is at the initiation of or during the first cycle of chemotherapy,baseline blood uric acid greater than 8 mg/dL (473 mol/L) at screening.
If newly diagnosed NHL patient with blood uric acid no greater than 8 mg/dL at screening, the patient must be diagnosed with Stage III or IV non-Hodgkin's lymphoma with high tumor burden which will be high risk of TLS defined, with one or more of following below: A. Burkitt lymphoma/leukemia or -lymphoblastic lymphoma, and/or B. Has at least one of lymph node or tumor, the diameter >5 cm, and/or C. Lactate dehydrogenase (LDH) no less than 2 times the upper limit of normal (ULN).
If newly diagnosed AL patient is with blood uric acid no greater than 8 mg/dL at the screening but with a high risk of TLS defined with one of the following below criteria: A. White blood cell (WBC) no less than 100.0 10-9/L, or B. WBC < 100.0 10-9/L with LDH no less than 2 ULN.
The patient will receive the chemotherapy, and will be confined in hospital for at least 14 days after first dose of rasburicase.
Exclusion criteria:
Acute promyelocytic leukemia
Patient who has been treated or planned to receive allopurinol within 72 hours of rasburicase administration.
Patients with abnormal liver or renal function: alanine aminotransferase (ALT) >5 ULN, total bilirubin >3 ULN, serum creatinine >3 ULN.
Documented history of hereditary allergy or asthma.
Patients with known deficiency of glucose-6-phosphate dehydrogenase (G6PD), or a history of hemolytic disease or methemoglobinemia.
Patients with severe infection or active bleeding.
Previous therapy with urate oxidase.
Hypersensitive reaction against rasburicase or any of the other ingredients of the study drug.
Patient is not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures.
Pregnant or breastfeeding woman.
Woman of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy (see contraceptive guidance in Appendix A).
Male participant with a female partner of childbearing potential not protected by highly-effective method(s) of birth control
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
investigational site CHINA
City
China
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Pediatric Patients With Non-Hodgkin's Lymphoma and Acute Leukemia
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