TumorsPhase 4NCT00230217
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
A Phase 4 study testing Rasburicase (SR29142) in people with Tumors and Hyperuricemia, run by Sanofi at 7 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tumors, Hyperuricemia, Tumor Lysis Syndrome
- What is being tested?
- Rasburicase (SR29142)
- How many people
- 94 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2004to Jul 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Meets one of the following risk criteria for tumor lysis syndrome (TLS):
- A patient is at high risk for TLS if he/she presents with:
- Hyperuricemia of malignancy (plasma uric acid > 7.5 mg/dL);
- A diagnosis of a very aggressive lymphoma/leukemia based on the Revised European-American Lymphoma (REAL) classification of lymphoma/leukemia;
- Acute myeloid leukemia (AML);
- Chronic myeloid leukemia (CML) in blast crisis; or
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- High grade myelodysplastic syndrome (refractory anemia with excess blast, refractory anemia with excess blast in transformation, or chronic myelomonocytic leukemia) only if they have > 10% bone marrow blast and are given aggressive treatment similar to AML
- A patient is at potential risk for TLS if he/she presents with:
- A diagnosis of an aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria:
- Lactate dehydrogenase (LDH) > 2 x upper limit of normal (ULN)(IU/L)
- Stage III-IV disease
- Stage I-II disease with 1 lymph node/tumor > 5 cm in diameter
- Patients previously treated with a uricolytic agent or not at their first relapse or refractory disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3. ECOG equivalent derived from Karnofsky performance scale 100-30 or Lansky performance score 100-30 (patients < or = 16 years of age) may also be used.
- Life expectancy >3 months
- Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).
- Signed written informed consent
Who cannot join
- History of established diagnosis of asthma or severe life-threatening atopic allergy
- Hypersensitivity to uricases or any of the excipients
- Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or history of hemolysis indicative of G6PD deficiency
- Pregnant or lactating
- Concomitant treatment with any investigational drug
- Planned treatment with rituximab
- Receipt of rituximab within the 12 month period prior to study entry
- Unwilling or unable to comply with the requirements of the protocol
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Alta Bates Comprehensive Cancer Center
Berkley, California, 94704
Rocky Mountain Cancer Center
Denver, Colorado, 80218
University of Florida Health Science Center at Jacksonville
Jacksonville, Florida, 32209
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506-9162
University of Oklahoma HSC
Oklahoma City, Oklahoma, 73104
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, 19104
New York Medical College
Valhalla, New York, 10595
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Tumors, Hyperuricemia, Tumor Lysis Syndrome
- Being tested
- Rasburicase (SR29142)
- Keywords
- Relapse, Refracturing, Leukemia, Lymphoma, Solid Tumor
- Medical subject headings
- Neoplasms, Hyperuricemia, Tumor Lysis Syndrome, Recurrence, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rasburicase (SR29142)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive response based on plasma uric acid levels.
Measured: up to 48 hours after last administration.
Secondary outcomes (1)
safety assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230217
- Sponsor's protocol ID
- EFC5339
- Status last verified
- Mar 2009
- First submitted
- 28 Sep 2005
- Last updated
- 30 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00230217
- Acronym / sponsor ID
- EFC5339
- Conditions
- Tumors, Hyperuricemia, Tumor Lysis Syndrome
- Keywords
- Relapse, Refracturing, Leukemia, Lymphoma, Solid Tumor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 30 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Meets one of the following risk criteria for tumor lysis syndrome (TLS):
- Patients previously treated with a uricolytic agent or not at their first relapse or refractory disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3. ECOG equivalent derived from Karnofsky performance scale 100-30 or Lansky performance score 100-30 (patients < or = 16 years of age) may also be used.
- Life expectancy >3 months
- Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).
Key exclusion criteria (8 listed)
- History of established diagnosis of asthma or severe life-threatening atopic allergy
- Hypersensitivity to uricases or any of the excipients
- Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or history of hemolysis indicative of G6PD deficiency
- Pregnant or lactating
- Concomitant treatment with any investigational drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rasburicase (SR29142) | Drug | – |
Primary outcome
Positive response based on plasma uric acid levels.
Time frame: up to 48 hours after last administration.
1 secondary outcome
safety assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rasburicase (SR29142) in people with Tumors and Hyperuricemia, run by Sanofi at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive response based on plasma uric acid levels. (time frame: up to 48 hours after last administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2009.