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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Tumor Lysis Syndrome, Cancer, Hyperuricemia

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Plasma Uric Acid Responder

Outcome Time Frame:

Day 3 through Day 7

Safety Issue:

No

Principal Investigator

International Clinical Development

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC4978

NCT ID:

NCT00230178

Start Date:

April 2004

Completion Date:

December 2007

Related Keywords:

  • Tumor Lysis Syndrome
  • Cancer
  • Hyperuricemia
  • 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)
  • Tumor Lysis Syndrome
  • Hyperuricemia

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
New York Methodist HospitalBrooklyn, New York  11215-3609
New York Medical CollegeValhalla, New York  10595
University of Rochester Medical CenterRochester, New York  14642
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Rocky Mountain Cancer CenterDenver, Colorado  80218
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Duke University Medical CenterDurham, North Carolina  27710
University of Pennsylvania Health SystemsPhiladelphia, Pennsylvania  19104-9104
UCLA Medical CenterLos Angeles, California  90095-7059
Oregon Health and Sciences UniversityPortland, Oregon  
Mary Babb Randolph Cancer CenterMorgantown, West Virginia  26506
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
University of Florida Health Science Center at JacksonvilleJacksonville, Florida  32209