Myelodysplastic Syndrome Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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:

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

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

280

Study ID:

NCT00230178

Recruitment Status:

Completed

Sponsor:

Sanofi

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There are 15 Locations for this study

See Locations Near You

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, United States

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

280

Study ID:

NCT00230178

Recruitment Status:

Completed

Sponsor:


Sanofi

How clear is this clinincal trial information?

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