Tumor Lysis SyndromePhase 3NCT00230178
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
A Phase 3 study testing Rasburicase (SR29142) and Allopurinol in people with Tumor Lysis Syndrome and Cancer, run by Sanofi at 15 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor Lysis Syndrome, Cancer, Hyperuricemia
- What is being tested?
- Rasburicase (SR29142) and Allopurinol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 15 sitesUnited States
- Study dates
- Apr 2004to Dec 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets high risk or at potential risk 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 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, chronic myelomonocytic leukemia, and refractory anemia with excess blast in transformation) only if they have > 10% bone marrow blast involvement and are given aggressive treatment similar to AML.
- A patient is at potential risk for TLS if he/she presents with:
- A diagnosis of 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 at least 1 lymph node/tumor > 5 cm in diameter
- In addition to the above-mentioned eligibility criteria, the patients should have the following criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- Age >= 18 years
- Life expectancy > 3 months
- Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for 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
None listed.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
Massachusetts General Hospital
Boston, Massachusetts, 02114
New York Methodist Hospital
Brooklyn, New York, 11215
Roswell Park Cancer Institute
Buffalo, New York, 14263
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Duke University Medical Center
Durham, North Carolina, 27710
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Florida Health Science Center at Jacksonville
Jacksonville, Florida, 32209
UCLA Medical Center
Los Angeles, California, 90095
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506-9162
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, 19194
Oregon Health and Sciences University
Portland, Oregon, 97201
University of Rochester Medical Center
Rochester, New York, 14642
New York Medical College
Valhalla, New York, 10595
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Tumor Lysis Syndrome, Cancer, Hyperuricemia
- Being tested
- Rasburicase (SR29142), Allopurinol
- Keywords
- Hyperuricemia, Tumor lysis syndrome, Leukemia, Lymphoma, Myelodysplastic Syndromes, Solid tumor cancers, Solid Tumor cancers with hyperuricemia Hyperuricemia (cancer patients only), Tumor lysis syndrome (cancer patients only)
- Medical subject headings
- Tumor Lysis Syndrome, Neoplasms, Hyperuricemia, Leukemia, Lymphoma, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rasburicase (SR29142)Drug
30-min IV infusion
AllopurinolDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Rasburicase alone given as a single agent for 5 days Receives: Drug: Rasburicase (SR29142) |
| Arm B | Experimental | 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) Receives: Drug: Rasburicase (SR29142); Drug: Allopurinol |
| Arm C | Active comparator | Oral allopurinol alone given as a single agent for 5 days Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Uric Acid Responder
Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 <7.5 mg/dl.
Measured: Day 3 through Day 7
Secondary outcomes (2)
Plasma Uric Acid
Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values
Measured: Day 1 to Day 7
Time to Uric Acid Control
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.
Measured: Day 1 to Day 7
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 startApr 2004
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tumor Lysis SyndromeStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- International Clinical Development, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230178
- Sponsor's protocol ID
- EFC4978
- Status last verified
- Jan 2010
- First submitted
- 28 Sep 2005
- Last updated
- 12 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00230178
- Acronym / sponsor ID
- EFC4978
- Conditions
- Tumor Lysis Syndrome, Cancer, Hyperuricemia
- Keywords
- Hyperuricemia, Tumor lysis syndrome, Leukemia, Lymphoma, Myelodysplastic Syndromes, Solid tumor cancers, Solid Tumor cancers with hyperuricemia Hyperuricemia (cancer patients only), Tumor lysis syndrome (cancer patients only)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 30 Sep 2005 (estimated)
- Results
- Posted 31 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Rasburicase (SR29142)Rasburicase alone given as a single agent for 5 days |
| Arm B | Experimental | Drug: Rasburicase (SR29142), Drug: AllopurinolRasburicase 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) |
| Arm C | Active comparator | Drug: AllopurinolOral allopurinol alone given as a single agent for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Meets high risk or at potential risk for tumor lysis syndrome (TLS):
- In addition to the above-mentioned eligibility criteria, the patients should have the following criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- Age >= 18 years
- Life expectancy > 3 months
Key exclusion criteria (0 listed)
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)30-min IV infusion | Drug | Arm A, Arm B |
| AllopurinolOral administration | Drug | Arm B, Arm C |
Primary outcome
Plasma Uric Acid Responder
Time frame: Day 3 through Day 7
Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 <7.5 mg/dl.
2 secondary outcomes
Plasma Uric Acid
Time frame: Day 1 to Day 7
Time to Uric Acid Control
Time frame: Day 1 to Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
International Clinical Development study director
Sanofi
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rasburicase (SR29142) and Allopurinol in people with Tumor Lysis Syndrome and Cancer, run by Sanofi at 15 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 18 inclusion and 0 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 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Plasma Uric Acid Responder (time frame: Day 3 through Day 7). 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 12 Jan 2010.