Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
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
1 other identifier
interventional
280
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2004
Typical duration for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 28, 2005
CompletedFirst Posted
Study publicly available on registry
September 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
December 31, 2009
CompletedJanuary 12, 2010
January 1, 2010
3.7 years
September 28, 2005
July 22, 2009
January 8, 2010
Conditions
Keywords
Outcome Measures
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.
Day 3 through Day 7
Secondary Outcomes (2)
Plasma Uric Acid
Day 1 to Day 7
Time to Uric Acid Control
Day 1 to Day 7
Study Arms (3)
Arm A
EXPERIMENTALRasburicase alone given as a single agent for 5 days
Arm B
EXPERIMENTALRasburicase 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 COMPARATOROral allopurinol alone given as a single agent for 5 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (15)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- International Clinical Development, Clinical Study Director
- Organization
- Sanofi-aventis
Study Officials
- STUDY DIRECTOR
International Clinical Development
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 28, 2005
First Posted
September 30, 2005
Study Start
April 1, 2004
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
January 12, 2010
Results First Posted
December 31, 2009
Record last verified: 2010-01