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CompletedNCT00230178Updated Jan 12, 2010Results posted

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

A Phase 3 interventional study of Rasburicase (SR29142) and Allopurinol in Tumor Lysis Syndrome, Cancer and Hyperuricemia, sponsored by Sanofi. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-01-12.

Sponsored by Sanofi · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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)
03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's enrollment of 280 is above the median of 50 across 6,515 interventional studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  1. 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
    • 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:

  2. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
  3. Age >= 18 years
  4. Life expectancy > 3 months
  5. 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).
  6. Signed written informed consent
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
280 participants (actual)

Study arms

  • Experimental
    Arm A

    Rasburicase alone given as a single agent for 5 days

    Drug: Rasburicase (SR29142)

  • Experimental
    Arm B

    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)

    Drug: Rasburicase (SR29142) · Drug: Allopurinol

  • Active comparator
    Arm C

    Oral allopurinol alone given as a single agent for 5 days

    Drug: Allopurinol

Interventions

  • DrugRasburicase (SR29142)

    30-min IV infusion

  • DrugAllopurinol

    Oral administration

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 3 through Day 7

Secondary outcomes

  1. Plasma Uric Acid

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

    Time frame: Day 1 to Day 7

  2. 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.

    Time frame: Day 1 to Day 7

07

Results

Posted Dec 31, 2009

Participant flow

Participant flow — Overall Study
MilestoneRasburicaseRasburicase + AllopurinolAllopurinol
Started949393
Treated929291
Completed908686
Not completed477
Withdrew: Adverse event152
Withdrew: Withdrawal by subject001
Withdrew: Various other reasons324

Outcome measures

PrimaryPlasma 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.

Time frame:
Day 3 through Day 7
Reported as:
Number · Participants
Plasma Uric Acid Responder
ParticipantsRasburicaseRasburicase + AllopurinolAllopurinol
Responder807260
Non-Responder122031
Statistical analysis
  • Rasburicase vs Allopurinol · Wilson's method · p = 0.0009 · Difference in response rate %: 21 · 95% CI 8.6 to 32.7
  • Rasburicase + Allopurinol vs Allopurinol · Wilson's method · p = 0.0632 · Difference in response rate %: 12.3 · 95% CI -0.9 to 25.0
SecondaryPlasma Uric Acid

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

Time frame:
Day 1 to Day 7
Reported as:
Mean · mg*h/dL
Plasma Uric Acid
mg*h/dLRasburicaseRasburicase + AllopurinolAllopurinol
Plasma Uric Acid77.25 ± 57.17108.05 ± 70.49646.22 ± 285.29
Statistical analysis
  • Rasburicase vs Allopurinol · ANOVA · p = <0.0001
  • Rasburicase + Allopurinol vs Allopurinol · ANOVA · p = <0.0001
SecondaryTime 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.

Time frame:
Day 1 to Day 7
Reported as:
Median · Hours
Time to Uric Acid Control
HoursRasburicaseRasburicase + AllopurinolAllopurinol
Time to Uric Acid Control4.1 (4.0 to 4.5)4.1 (3.9 to 4.5)27.0 (4.0 to 49.0)

Adverse events

Collected over Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Rasburicase—36/92 (39.1%)91/92 (98.9%)
Rasburicase + Allopurinol—32/92 (34.8%)92/92 (100%)
Allopurinol—29/91 (31.9%)90/91 (98.9%)
Most frequent serious events
Showing 10 of 86
Most frequent serious events
EventRasburicaseRasburicase + AllopurinolAllopurinol
Neutropenic infectionInfections and infestations5/924/928/91
Febrile neutropeniaBlood and lymphatic system disorders4/923/925/91
Neutropenic sepsisInfections and infestations5/921/923/91
Tumor lysis syndromNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/921/923/91
Respiratory failureRespiratory, thoracic and mediastinal disorders2/923/921/91
Pulmonary haemorrhageRespiratory, thoracic and mediastinal disorders1/923/920/91
Multi-organ failureGeneral disorders2/922/922/91
ThrombocytopeniaBlood and lymphatic system disorders2/921/920/91
Atrial fibrillationCardiac disorders2/921/920/91
Abdominal painGastrointestinal disorders2/920/921/91
Most frequent other events
Showing 10 of 127
Most frequent other events
EventRasburicaseRasburicase + AllopurinolAllopurinol
NauseaGastrointestinal disorders53/9256/9250/91
PyrexiaGeneral disorders44/9256/9251/91
DiarrhoeaGastrointestinal disorders52/9252/9251/91
ThrombocytopeniaBlood and lymphatic system disorders51/9249/9248/91
NeutropeniaBlood and lymphatic system disorders49/9244/9245/91
Oedema peripheralGeneral disorders46/9240/9239/91
HypocalcaemiaMetabolism and nutrition disorders31/9241/9244/91
AnaemiaBlood and lymphatic system disorders31/9231/9243/91
HypokalaemiaMetabolism and nutrition disorders35/9232/9236/91
HyperglycaemiaMetabolism and nutrition disorders27/9234/9235/91

Baseline characteristics

Age, Customized
Age, Customized(participants)RasburicaseRasburicase + AllopurinolAllopurinolTotal
<65 years636569197.0
>=65 years31282483.0
Sex: Female, Male
Sex: Female, Male(Participants)RasburicaseRasburicase + AllopurinolAllopurinolTotal
Female354229106.0
Male595164174.0
08

Study locations

15 sites
  • Alta Bates Comprehensive Cancer Center
    Berkeley, California 94704, United States
  • UCLA Medical Center
    Los Angeles, California 90095, United States
  • Rocky Mountain Cancer Center
    Denver, Colorado 80218, United States
  • University of Florida Health Science Center at Jacksonville
    Jacksonville, Florida 32209, United States
  • Ochsner Clinic Foundation
    New Orleans, Louisiana 70121, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • New York Methodist Hospital
    Brooklyn, New York 11215, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
  • New York Medical College
    Valhalla, New York 10595, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Oregon Health and Sciences University
    Portland, Oregon 97201, United States
  • University of Pennsylvania Health Systems
    Philadelphia, Pennsylvania 19194, United States
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • Mary Babb Randolph Cancer Center
    Morgantown, West Virginia 26506-9162, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00230178
Lead sponsor
Sanofi
First posted
Sep 30, 2005
Start date
Apr 2004
Primary completion
Dec 2007
Completion
Dec 2007
Results posted
Dec 31, 2009
Last update
Jan 12, 2010

Study contacts

International Clinical Development
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

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